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DIA’s highly rated instructor-led training courses are designed to inform and educate professionals and experts on critical issues related to pharmaceuticals, biotechnology, and medical products.

Courses on more than 50 topics provide professionals from industry, government, and academia with the opportunity to exchange ideas, knowledge, and best practices with peers and expert instructors. Courses offered range from European regulatory affairs to drug development to safety inspection preparation.

In addition to expert instruction, each course participant receives a comprehensive set of lesson materials that is consistent across courses.

Review the list of courses below to get more information on:
  •     What You will Learn in Pharmaceutical, Biotechnology, Medical Devices, and Related Areas
  •     Specific Learning Objectives
  •     Target Audiences
  •     Contact Information
Sign up today for DIA’s instructor-led courses and discover why these innovative professional development forums are valued by a growing global audience of pharmaceutical, biotechnology, medical device, and other professionals.

Adaptive Design in Clinical Trials: When and How to Apply

Overview

There has been a considerable interest and increase in the application of adaptive designs in the pharmaceutical industry, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010. Adaptive design has the potential to reduce the cost and length of drug development, and/or improve the probability of success and de-risk drug development. However, there is a lot of uncertainty and questions around the use of adaptive design. In this course we will identify opportunities in early and late phase development where adaptive design may be applied, and use practical examples to demonstrate how to appropriately design and implement such trials in consensus with FDA Guidance.
Course Level: Beginner/Intermediate

Course level:

TRNG

Advanced GCP Study Monitoring

Overview

Clinical Research Monitors perform a critical role in the conduct of a clinical trial. As the primary liaison between the sponsor and the site, the monitor must verify that the clinical trial is conducted according to Good Clinical Practice, the safety and rights of subjects are protected, the Investigational Medicinal Product is handled correctly and the data is of the highest quality. This course will expand and strengthen the monitoring skills of Clinical Research Associates, enabling them to perform their role
more proficiently and effectively.Using case studies, monitors will learn how to handle monitoring problems and proactively manage risks
before they become audit findings later. This course includes an invaluable “shared experience session” which will enable colleagues to discuss monitoring challenges they face.

  • Research misconduct
  • Risk Management for the Monitor
  • Elements of Corrective and Preventive Action Plans
  • Advanced Monitoring Techniques and Tools
  • Benchmarking for site performance evaluation
  • Source document/data evaluation
  • Electronic source data verification

Course level:

TRNG

Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

Overview

Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities.   Biopharmaceutical sponsors are expected to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations. An understanding of these factors is a prerequisite for an effective system of signal triage, prioritization, evaluation and decision-making. This basic to intermediate level course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on practical exercises and discussions.

Course level:

TRNG

Advanced Workshop on QPPV Tool Box - Your Key to Success

Overview

The workshop is designed to include small group interaction and discussions, led by our expert instructor, and is based on suggestions from the QPPVs themselves. The workshop will allow you to be more efficient in solving the problems in your daily business, learn the right thinking processes to land at good results and hear from solutions from other in similar situations.

Course level:

TRNG

Advanced Workshop on QPPV Tool Box - Your Key to Success

Overview

The workshop is designed to include small group interaction and discussions, led by our expert instructor, and is based on suggestions from the QPPVs themselves. The workshop will allow you to be more efficient in solving the problems in your daily business, learn the right thinking processes to land at good results and hear from solutions from other in similar situations.

Course level:

TRNG

An Introduction to Product Information Management

Overview

PIM is a new method of submitting product information in the Centralised Procedure (CP). With more than 20 different languages in the EU leading to 1000 or more documents for a single trade name, there is an increased burden on applicants and authorities to handle information for packaging leaflets and product characteristics, especially during the time critical translation process. PIM has been introduced by the EMEA to increase efficiency during exchange of product information and improve the quality and constancy of product information.

This training course is designed to give the participants a good understanding about Product Information Management, the PIM submission process and variations, the translation process and comment handling as well as the exchange standard and templates used.

Highlights:

  • PIM Essentials
  • Initial Submissions
  • Comment Handling
  • Translation Process
  • PIM Variations
  • LAT – The Light Authoring Tool

Course level:

TRNG

Art of Writing a Clinical Overview

Overview

DIA is pleased to present this introductory training course which will provide an in-depth analysis of the preparation of a Clinical Overview for pharmaceutical products (drugs and biologics) in accordance with ICH guidelines concerning development of Module 2.5 of a Common Technical Document (CTD).

Course level:

TRNG

Basics of the IND Phase

Overview

DIA is pleased to present a four-part course in which you will learn about FDA regulations and expectations for the content, submission, and review of Investigational New Drug (IND) Products and the importance of regulatory strategy. This online course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, OTC products, or traditional biologics.

Course level:

TRNG

Basics of the NDA Phase

Overview

This training course will discuss the aspects of New Drug Application (NDA) preparation. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.
Course Level: Beginner

Course level:

TRNG

Benefit-Risk Management

Overview

This intensive course explores current opportunities made possible by the legislation, advances in information technology and new scientific methodology to enhance and modernise the approaches in the product lifecycle management.
The course starts with the current regulatory thinking about the Benefit-Risk methodology, including the relevant projects of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP). It gives a basis for the second part of the course, exploring the new European Benefit-Risk management planning – a notion stemming from the experience gathered over the past ten years with the EU Risk Management Plans (EU-RMPs). Participants will learn how to take advantage of the efficacy follow-up options given by the EU law and guidelines. A practical training in solving key aspects of the Benefit-Risk management based on real-life examples is included.

Participants will be provided with preparatory material in order to better participate at the group exercises onsite.

Course level:

TRNG

Biosimilar Development: Strategies and Regulatory Requirements for Global Market Entry

Overview

Do you have a strategy for biosimilar development? Extensive use of biologic products have become the mainstay in personal treatment regimens across an ever increasing array of disease states including cancer, diabetes, various forms of arthritis, Chron’s disease and multiple sclerosis. The prohibitive cost of these novel biopharmaceuticals have restricted broader introduction to populations across the globe.  Patent expirations for these biopharmaceuticals offer new opportunities to introduce cost effective alternatives to a greater number of patients.
These follow-on biologics have garnered great interest for their cost-effective benefits in patient care as well as development opportunities for sponsors who see a new revenue stream.  However, the pathway to commercialization is complicated by regulatory challenges, manufacturing hurdles as well as challenges in understanding the needed data requirements to establish a viable safe and effective product compared to the originator. 
This comprehensive, high-level training program will provide a tailored learning experience to those seeking to understand how a follow-on biologic or candidate biosimilar product is developed, regulated and registered for global commercialization. Information will also be provided on remaining issues yet to be resolved that may further complicate successful integration of biosimilars into common therapeutic practice. Information on global market status of follow-on biosimilars, governing regional regulations and pending issues facing further global commercialization will be reviewed.
Course Level:  Intermediate

Course level:

TRNG

Building the eCTD: Practical Solutions to Compile Electronic Submissions

Overview

This course will offer insight into the compilation of the eCTDs, share experience and best practice gained during eCTD submissions and explain the eCTD review und lifecycle process. Especially eCTD submissions in the GCC region will be addressed in detail.

Course level:

TRNG

Clinical Aspects of Quality Risk Management and Quality by Design

Overview

This course will deliver an in-depth overview of risk-based quality management, including how to assess risk and improve quality within an organisation. As an introduction, general risk management concepts and methodologies will be presented as the basis for Quality Risk Management (QRM) in clinical development and pharmacovigilance. This will be followed by a review of applicable and meaningful metrics for clinical development and pharmacovigilance processes, how these can be best applied, and what change management challenges need to be considered. This is a beginner/intermediate-level course.

Course level:

TRNG

Clinical Project Management

Overview

The practical hands-on activities in this course will help participants create a custom operations plan for clinical trials. The course covers clinical project management from the planning stage through development, execution, and project close-out.
Course Level: Intermediate

Course level:

TRNG

Clinical Project Management in Europe

Overview

As clinical trials become more complex and there is increasing demand for efficiency and cost effectiveness, the knowledge and skills required to manage a clinical project are crucial. The course provides a foundation in clinical project management from defining and planning the project to managing, controlling and closing the project.  Using an interactive approach based on real case studies, participants will be taught how to apply project management strategies, tools and techniques to their clinical trial projects.

Course level:

TRNG

Clinical Statistics for Nonstatisticians

Overview

This course answers common questions and addresses topics such as confidence intervals, hypothesis testing, trial designs, and methods for establishing non-inferiority.  This course will increase the level of statistical knowledge of nonstatisticians so that collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved.
Course Level: Beginner

Course level:

TRNG

Clinical Trial Audits in Practice

Overview

This clinical trial audit course is designed to provide training on methods and approaches to plan, conduct and report on different types of audits with examples of practical implementation and discussion of challenges. Recent trends and updates in clinical trial legislation and guidance, increased use of electronic systems in clinical trials as well as implementation of risk management principles are imbedded. The course is a combination of presentations, panel discussions and exercises by an experienced team of auditors and EMA and inspector representatives.

Course level:

TRNG

Clinical Trial Management Essentials

Overview

This training course provides a comprehensive overview of the essential elements of clinical trial management and the overall drug development process, using real case studies, practical examples and group exercises. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study.

Course level:

TRNG

Comprehensive Training on European Regulatory Affairs including Different Registration Procedures and Variations: Expert Overview

Overview

The ‘Comprehensive Training on European Regulatory Affairs including different Registration Procedures and Variations: Expert Overview’ training course is a key course developed by DIA in Europe. This course provides a comprehensive description and discussion of the regulatory environment. The course focuses on Europe but also looks at regulations in other regions including the USA and Japan.

Your benefit:

This is a unique opportunity to learn, understand and discuss the main aspects of drug regulations in Europe directly from key European Regulators and from the large experience in the pharmaceutical industry and to acquire key recommendations for a successful implementation of your regulatory strategy and operations.

Key Topics:

  • Drug regulations
  • Role of regulatory affairs in drug - development / approval / marketing
  • Efficient interactions between regulatory agencies and the pharmaceutical industry
  • Regulatory strategy
  • Key differences of international regulatory environments

Course level:

TRNG

Developing Standard Operating Procedures

Overview

How does a standard operating procedure (SOP) withstand US Food and Drug Administration (FDA) scrutiny? One of the best ways to ensure that an organization meets its business and regulatory obligations is to follow SOPs, which are standardized procedures and processes to ensure that similar tasks are done the same way every time. This online training course explores what SOPs are, their uses, how to write them, their importance to an organization, and how specific SOPs are used in various organizations. Course Level: Beginner

Course level:

TRNG

Development of a Clinical Study Report

Overview

DIA is pleased to present this fast-track introductory course which is designed for professionals new to clinical development and Clinical Study Report preparation. The Clinical Study Reports for submission to the Health Authorities are required to be in compliance with the International Conference on Harmonization (ICH) guidelines. The reports must meet high quality standards in providing a concise yet comprehensive summary of the study. This course will provide the latest strategies for preparing clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.
Course Level: Beginner

Course level:

TRNG

Diagnosis and Management of Drug-Induced Liver Injury (DILI): Clinical Trials and Post-Marketing

Overview

This new DIA training course is entirely dedicated to Drug-Induced Liver Injury (DILI). It is led by a Hepatologist with extensive experience in clinical assessment of DILI and who published ‘RUCAM’ the widely used causality assessment method of DILI. The course will cover the progress that has been made in the clinical detection and prevention of DILI in clinical trials and in post marketing phase. Regulatory guidelines need to be understood for an optimal assessment of DILI cases. Better use of typical tools will be emphasised in order to improve patient safety and drug monitoring in new drug development, especially in large populations. This course will provide tools, explanations, examples and several exercises for a better understanding of DILI and how best to apply that knowledge in day-to-day work.

Course level:

TRNG

Electronic Submissions: The Next Era of Electronic Submissions

Overview

As part of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the reauthorization of the Prescription Drug User Fee Act (PDUFA V), there will soon be a mandate for the use of electronic submissions, specifically the electronic common technical document (eCTD) in the US.  There already exists a mandate in Europe for marketing applications that are eligible for Centralized Procedure review.  Electronic submissions are accepted globally in various formats and there are well established standards being used for their creation.
This course will focus on the technical foundations of electronic submissions and their use as well as the practicalities and processes of creating them.  The use of technology and the specifications needed for various types of submissions will be presented along with common issues and challenges.  The US requirement for the submission of datasets will also be addressed.
Examples of how standards can be employed to generate and track applications will be discussed, and activities on locating current guidance and submission metadata will all be part of this interactive course.
Course Level: Beginner
Key Topics: 
eSub/eCTD Guidance, vocabulary and terminology, document and data standards, mapping from regulation to submission

Course level:

TRNG

Enterprise Resource Management

Overview

Learn how to build, implement, and maintain a resource management business and supporting information technology (IT) system. Understand how to accommodate the reverberations of cultural change and how to get buy-in from all the key stakeholders.
Course Level: Beginner

Course level:

TRNG

Essentials and Overview of the Regulatory Framework in Europe

Overview

The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. Different steps and timelines for the various procedures will be covered. An introduction to pharmacovigilance, variations and renewals will be given in the context of the lifecycle. In addition, the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed.

The course will cover the current registration systems available for approval of human medicinal products:

  • Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
  • Directive 2001/83/EC ‘the Community Code’ on the Mutual Recognition Procedures

A case study will enable participants to apply the freshly gained knowledge into their daily practice.

This is a hands-on course. It is necessary that you bring your laptop/electronic device with you.

Course level:

TRNG

Essentials of Project Management

Overview

Walk away being able to produce a defensible schedule, a solid staffing plan, and a practical risk response plan in a biotech pharmaceutical/medical device world.
Course Level: Beginner

Course level:

TRNG

EU Regulation of In-Vitro Diagnostics

Overview

This course will give an overview of the current In-Vitro Diagnostic (IVD) Directive and will highlight anticipated future changes in the regulation. The basic philosophy of the existing system, including the definition of an IVD, will be explained, and borderlines to other products such as medical devices and laboratory equipment will be highlighted. The future IVD Regulation, which is substantially different from the current IVD Directive, will be discussed and major changes will be emphasised. The revised classification rules and the new requirements on performance evaluation will be explained.

The role of IVDs in personalised medicine, the benefit/risk based approach and the market approval for IVDs, which is different from those for medicinal products will be discussed. Differences between the EU and US systems for personalised medicine, and the current and new role of notified bodies, standards and Common Technical Specifications will be addressed.

Exercises will enable you to apply the principles learnt.

Course level:

TRNG

European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

Overview

This training course provides description and discussion of the complete spectrum of necessary regulatory procedures: marketing authorization registration procedures, variation procedures, renewal procedures and more. Expert instructors use practical examples and experiences to illustrate procedures. The course focuses on Europe but also reviews regulations in other regions including the US and Japan.
Course Level: Intermediate

Course level:

TRNG

Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

Overview

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

Course level:

TRNG

Executing and Controlling Biopharmaceutical Projects

Overview

Learn the elements of a project plan, how to use the plan to execute and control a project, and how to motivate team members to exceed the project goals.
Course Level: Beginner

Course level:

TRNG

Fundamentals of Clinical Research Monitoring

Overview

Interactive lecture and hands-on workshop training methods provide participants with the tools to design and manage clinical studies.
Course Level: Beginner

Course level:

TRNG

Fundamentals of Project Management for the Nonproject Manager

Overview

This online training course will focus on the basic principles of project management and how they can be applied to best meet the needs of your projects.  You will take away a set of project management skills and techniques that can be immediately put to use.
Course Level: Beginner

Course level:

TRNG

Global CTD Dossier – Regulatory aspects and focus on quality documentation including concepts of Quality by Design

Overview

High quality of a registration dossier facilitates the registration procedure - Essential for Generics! This course provides a comprehensive description on the Common Technical Dossier structure – completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course provides an excellent opportunity to gain an overview of regulatory aspects and includes discussion of the relevant legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail, taking into account the recent ICH-Q guidelines. The course is for new developments, but is also very much attractive for Generics. In addition, this training course addresses Quality by Design aspects and issues.
Participants will be involved in case studies, group works and have to present the outcome.

Course level:

TRNG

Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America and Other Emerging Markets

Overview

This intermediate course will provide participants practical real-world, actionable information on the nature and development of global regulatory strategies for drug development, with a focus on markets located outside the United States and Europe.  Descriptions of the local regulatory environments and requirements for drug developmnet will be enhanced by case examples and by practical experiences in Asia Pacific, Latin America, Africa, and other emerging markets. 

Course level:

TRNG

Good Clinical Practices for the Clinical Research Professional

Overview

Gain the basic knowledge required to conduct clinical trials, including information about subject safety, regulations, and the practicalities of performing research studies.
Course Level: Beginner

Course level:

TRNG

High Performance Biopharm Teams

Overview

The “SOFT SKILLS” of project management. These are the skills that separate the fast track project leaders from the others.  Everyone talks about them.  But do we really know how to master them? 
Through a variety of interactive and insightful exercises, case studies, and discussions, you will learn to orchestrate a synergistic team environment.
Course Level: Beginner

Course level:

TRNG

How to Manage a Successful Health Authority Interaction?

Overview

Health Authority (HA) meetings with the major HAs (ICH region) are an essential part of drug development. Each pharmaceutical company will sooner or later be faced with such meetings. This important course covers HA meetings in the EU and in the US.

This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.

Course level:

TRNG

How to Prepare for a Safety Inspection

Overview

Every pharmacovigilance department will, at one time or another, undergo a government or health authority inspection as well as audits by vendors, partners, suppliers, internal auditors, and others.  DIA is pleased to present this introductory online course that will teache you how to prepare for an audit/inspection from the time of the receipt of the annoucement (or of the arrival of the inspectors at your doorstep) to conclusion of the audit.
Course Level: Beginner

Course level:

TRNG

How to Prepare for Pharmacovigilance Audits and Inspections in Europe

Overview

Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.

Course level:

TRNG

HTA for Non-HTA User

Overview

Given the increasing role of HTA in the pricing and reimbursement decision making across different jurisdictions, there is an increasing need for an introductory course which will provide new users with a sound overview of HTA and its application.

The course consists of theoretical sessions followed by practical workshops. It covers key HTA concepts and provides an overview of methods used in the evaluation of medical technology during pricing and reimbursement decision making process. The practical workshops allow participants to develop skills to interpret HTA findings and build pricing and reimbursement strategy based on HTA outcomes.

Course level:

TRNG

Innovative Statistical Approaches for Clinical Trials

Overview

This intermediate-advanced online course answers common questions and addresses topics such as modeling, multiplicity adjustments, non-inferiority, data mining, adaptive designs, Bayesian principles, and survival methods. This online course will increase the level of statistical knowledge of nonstatisticians so that collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved.

Course level:

TRNG

Introduction to Computer Systems Validation

Overview

Gain insight into the basics of computer validation, regulations applicable to computer system validation, how to plan computer system validation for the system’s lifecycle, and how to develop an organization’s own system instead of purchasing one.
Course Level: Beginner

Course level:

TRNG

Introduction to Portfolio Management and Performance Metrics

Overview

This highly interactive course will teach participants how to identify and consider the implications of managing performance metrics in their companies. It will provide case studies, simulation exercises, shared experiences, and lessons learned from others who have worked with performance metrics in their organizations. Tools and reference lists will be provided.
Course Level: Beginner

Course level:

TRNG

Introduction to Signal Detection and Data Mining

Overview

This introductory training course will review approaches to the implementation of signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US.  Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.

Topics discussed will include signal identification and assessment, application of available regulatory guidance documents, review of data visualization tools to facilitate signal detection and evaluation, and the use of EU GVP Module IX to structure and organize a signal management process.

Course level:

TRNG

Medical Affairs Training

Overview

Medical Affairs professionals in the health care product development business are now more involved in the product development and lifecycle than ever before.   The role and core competency expectations have evolved where many companies are seeking their team to apply their scientific and clinical knowledge to support business decisions related to product life cycle management.  DIA’s Medical Affairs Curriculum focuses on the essential clinical, regulatory, safety and business principles needed by Medical Affairs professionals.   DIA’s approach to medical affairs training highlights the importance of interdisciplinary education for health care providers working in the biopharmaceutical arena.

Course Level: Beginner-Intermediate

Course level:

TRNG

Medical Approach in Diagnosis and Management of ADRs

Overview

This annual training course, considered by many experts as one of the pillars of medical training in pharmacovigilance, focuses on how to use medical knowledge in the diagnosis and management of selected Adverse Drug Reactions (ADRs). ADRs of the main systems/organs will be presented and explained by experts in their medical domain in order to provide practical clues to understand and manage the serious reactions in clinical trials a well as in post authorisation.A medical approach is needed for the identification, labelling and understanding of ADR mechanisms. It can also help assess the probability that a medicinal product may have played a role in the occurrence of an adverse event. This is particularly useful for the first 2 or 3 cases of serious reactions occurring during clinical trials when important decisions must be taken regarding a new drug under development.

Course level:

TRNG

Medical Devices: Regulation and lifecycle management

Overview

This course will give clear and practical guidelines on how to navigate the development of a medical device in the regulatory landscape, and how to identify the correct development path. It focuses on Europe, but also addresses global standards.

Overview of the EU device legislative system and the principles and philosophy behind it will be discussed. Instructors will also explain the essential features of EU medical device regulation, such as essential requirements, risk classification, the relationship between risk classification and conformity assessment procedures and the role of notified bodies.

For medical devices that need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be described in detail.

Furthermore, the process of drafting a design dossier will be highlighted, both for medical devices and for combination products.

 

Course level:

TRNG

New Drug Product Development and Life Cycle Management

Overview

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed.  This course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and minimize the risks associated with shepherding a new drug candidate through the development process.
At the end of this course, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.
Course Level: Beginner

Course level:

TRNG

Non-Clinical Safety Sciences and Their Regulatory Aspects

Overview

This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.

Course level:

TRNG

Oversight of Clinical Monitoring: Trends and Strategies

Overview

DIA is pleased to present a three-part online training series focusing on clinical monitor oversight.  Hear from experienced faculty on the trends impacting monitors, requirements, approaches, selection, and how to manage a site monitor’s performance. This course also focuses on the elements of risk-based monitoring.
Course Level: Intermediate

Course level:

TRNG

Overview of Drug Development

Overview

This course will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development. During the course, we will discuss some of the challenges to conducting scientifically sound and ethical clinical trials and the continuing evolution of regulatory requirements.
Course Level: Beginner

Course level:

TRNG

Overview of Drug Development in Japan

Overview

Learn proven strategies for minimizing pharmaceutical development regulatory challenges in the United States and Japan.
Course Level: Beginner

Course level:

TRNG

Paediatric Investigation Plans (PIP)

Overview

This course will provide a full introduction to PIPs and the EU Paediatric Regulation. The course faculty are European-based leading experts from EMA and industry.

Topics will be presented through interactive lectures and hands-on workshop training. Overview of the Paediatric Investigation Plan (PIP) procedure and lifecycle, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs will be discussed. Case-studies and instructor-led group work on specific cases will be presented.

Course level:

TRNG

Post-Authorisation Studies

Overview

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed. There will be a chance to practice with real life examples, and participants are welcome to provide examples and questions in advance.

A PASS and PAES may be initiated, managed or financed by a Marketing Authorisation Holder (MAH) voluntarily, or pursuant to an obligation imposed by a competent authority. PASS as well as PAES can be integral parts of drug approval and continuous development. A PASS needs multi-departmental input within a company and approval at cross-organisational managerial level. It is the key to applying the right methodology for the correctly identified problem.

Course level:

TRNG

Postmarketing Drug Safety and Pharmacovigilance

Overview

Learn about the fundamentals of clinical drug safety and the key tools available for postmarketing pharmacovigilance. Discuss the application and inter-relationships of these tools, and consider future directions for the field. Gain knowledge of the latest changes in the US and EU regulations and best practices for compliance. Develop an in-depth understanding of the requirements and procedures that must be performed to protect patient safety and to remain in compliance with legal obligations in two key regulatory jurisdictions. Didactic presentations will be supplemented with case studies and practical exercises to reinforce learning. There will be ample time for Q&A with the faculty.

Course Level: Intermediate

Course level:

TRNG

Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing

Overview

This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post-marketing studies, and in the healthcare setting following product launch.

Regional developments in the GCC countries will also be highlighted.

Course level:

TRNG

Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing

Overview

This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post-marketing studies, and in the healthcare setting following product launch.

Regional developments in the GCC countries will also be highlighted.

Course level:

TRNG

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Overview

This comprehensive three day training course is designed to cover contemporary principles, definitions, regulatory expectations, and pragmatic approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with focus on the US and EU. Topics will span the life cycle of traditional innovative medicinal products, from first-in-human through the postmarketing phase. However, faculty will be prepared to discuss drug safety topics of interest to participants. The course will be delivered in a series of sessions at a basic to intermediate level; didactic presentations will be supplemented with real-world case studies and practical exercises. Active discussion with experienced faculty will be encouraged and the agenda will provide ample opportunities for Q&A.

Course level:

TRNG

Pre-Marketing Clinical Safety

Overview

DIA is presenting an intensive course for professionals involved in management of safety information of clinical trials in the EU. Participants will be guided through all the regulations and guidelines pertinent to pre-marketing safety in the EU.

The course offers an overview of all the current major methodological approaches and hands-on solutions for day-to-day challenges.

Attendees will learn how to produce Development Safety Update Reports (DSURs), and how to bridge a Development Risk Management Plan, EU-Risk Management Plan (EU-RMP) and Risk Evaluation and Mitigation Strategies (REMS) to be ready for a marketing authorisation application.

Course level:

TRNG

Premarketing Clinical Safety and Pharmacovigilance

Overview

Learn how to comply with evolving US and European (EU) regulations for clinical safety during premarketing development of traditional medicinal products. This basic two-day training course is designed to cover contemporary principles, definitions, regulatory expectations, and pragmatic approaches to drug safety for interventional clinical trials in key regulatory jurisdictions, with focus on the US and EU. Topics will cover approaches to drug safety from first-in-human through the peri-approval phase of innovative product development and will include FDA expectations on IND reporting (single cases and new aggregate assessments), as well as new EU legislation coming into force at end-2016. The course will be delivered in a series of modules; didactic presentations will be supplemented with real world case studies and practical exercises. Active discussion with experienced faculty will be encouraged and the agenda will provide ample opportunities for Q&A.  
Course Level: Beginner

Course level:

TRNG

Preparing for a US FDA Advisory Committee Meeting

Overview

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This course teaches best practices for preparing for an FDA Advisory Committee Meeting.
Course Level: Beginner

Course level:

TRNG

Project Information, Communication, and Knowledge Management

Overview

Manage the flow of information between team members and stakeholders.
Course Level: Beginner

Course level:

TRNG

Project Risk Management

Overview

Participants will use a Risk Tracker tool to apply the techniques discussed during the lectures in order to stimulate more in-depth understanding of the risk management process.
Course Level: Intermediate

Course level:

TRNG

Proven Strategies for Creating an Effective Clinical Research Program

Overview

With the pharmaceutical development process becoming increasingly competitive, complex, and global, it is necessary for clinical research professionals to clearly understand their roles and the roles of others they interact with. This knowledge helps them facilitate a pharmaceutical development process that is both timely and completed within budget.
Through interactive lectures and exercises, this online course will provide clinical research professionals with the knowledge and skill set needed to improve the pharmaceutical development process. Topics to be addressed include product development strategy, clinical trial management and development, project management, and quality concepts.
Course Level: Beginner

Course level:

TRNG

Quality by Design - Quality by Design - New concepts for Chemical and Biotech Product Development and Optimisation

Overview

Quality by Design (QbD) concepts are becoming the defacto best practice spearheaded by the FDA and EMA. But how can you implement ICH Q8-Q11 with confidence for small molecules and biotech products?
As part of our Chemical Manufacturing series, DIA brings together expert faculty from Regulatory agencies, academia and industry. ICH and DoE expertise will accompany you to building a practical knowledge base.

METHODOLOGY & OUTCOMES
By the end of this 2.5-day course, you will have enough knowledge and reference points to establish a Design Space and essential elements of the Control Strategy. Through a series of  case studies you will learn how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM).

Case scenarios include:

  • solid dosage form of a small molecule
  • manufacturing process for a biotech product

You will learn how to prioritise the potential critical formulation and process parameters with QRM, propose, execute and evaluate a DoE to define the critical parameters and eliminate non-critical parameters.
Knowledge Management will be introduced to keep the information and knowledge gained transparent and available for the full lifecycle of the product. The case study will investigate how a systematic approach to pharmaceutical development and optimisation, respectively, will be faster and will lead to robust processes. Potential internal savings and regulatory flexibility will be discussed with a key European regulator.
The course will also provide an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.

Course level:

TRNG

Regulatory Affairs for Biologics

Overview

Participants in this training course will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and cellular therapy, and the different ways that CBER and CDER view product development. The course will also discuss proven strategies to achieve regulatory success in the development of biologics.
Course Level: Intermediate

Course level:

TRNG

Regulatory Affairs: The IND, NDA, and Postmarketing

Overview

Fundamentals of IND/NDA submissions and Postmarketing Regulatory Requirements

Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of real-world and interactive lectures, workshops and online precourse modules. This basic to intermediate level training course focuses on prescription drugs and well characterized biological products. The requirements specific to generic drugs, biosimilars, devices, and OTC monograph products are not covered in detail.

Course level:

TRNG

Risk Management and Safety Communication Strategies

Overview

Risk Management Best Practices to Optimize Medicinal Product Safety

Risk Communication is increasingly important to everyone involved in the health care system, especially the patients whose lives we strive to improve.  This intermediate class will look at current initiatives and new strategies to advance the safe use of drugs through better communications in an attempt to maximize patient benefits while minimizing the risks of medicine use.
Course Level: Intermediate

Course level:

TRNG

Signal Management in Pharmacovigilance

Overview

The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions, including the data mining techniques for large volume ADR data analysis, relevant EMA guidelines as well as a future outlook.

The entire course is updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII. Time has been set aside for exercises, questions and discussions.

Participants will be provided with preparatory material in order to better participate at the group exercises onsite.

Course level:

TRNG

Strategies for Good Clinical Practice Audits

Overview

Learn basic knowledge of Good Clinical Practice audit programs and strategies.  This online course is designed to help you with types of audits and inspections, audit reporting, general procedures in preparing for a FDA inspection, role and findings of FDA inspections and how to successfully handle and respond to a FDA inspection. 
Course Level: Beginner

Course level:

TRNG

The Basics of Clinical Data Management From Start to End

Overview

This one day face-to-face course will introduce participants to the basic principles of clinical data management.  Relevant information and instruction will be covered on data management to include, data capture instrument design, data editing, data tracking, metrics, and much more.  This interactive course will allow participants the opportunity to run through a series of hands on exercises.
Course Level: Beginner

Course level:

TRNG

The development of biopharmaceuticals - The big picture, innovation and scientific requirements

Overview

The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions. Case-studies will be inserted for the practical application of knowledge gained.

The training will be delivered as presentations on individual topics, interspersed by case studies and conclude with an outlook on further developments in this fast moving field.

This 3-day training course focuses on drug development of biopharmaceuticals which have become the focus of pharmaceutical innovation and currently represent 30% to 50% of newly authorised medicinal products.

Participants will learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access. This covers the clinical trial stage, licensing and the life-cycle of these products. Specific development paths will be delineated, such as those for biosimilars and ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.

Course level:

TRNG

The Impact of Regulatory Affairs on Chemistry, Manufacturing & Controls (CMC)

Overview

Generics are becoming increasingly central in both industrialised countries and in developing countries. The overall requirements for generics will be detailed including problems in relation to generic substitution and falsified medicines.

The course will consider the important aspects for Active Pharmaceutical Ingredients (APIs), such as requirements to the production and supplier qualification and certification. The implementation of ICH Q11 will be discussed.

Bioequivalence testing is an integral part of the development both of new medicinal products and of generics. Revised EU guidance has been developed and the impact of the new guidance will be thoroughly discussed.

Globalisation is an important element in the production of drug substances and drug products to be licensed and marketed in Europe. This course will focus on three essential topics which are particularly influenced by production in a global environment.

The course will be taught with a combination of presentations by the faculty and work in small groups assisted by faculty members. A significant amount of time will be devoted to working on case studies. Results from the working groups will be presented to the full audience.


KEY TOPICS

API production/API supplier qualification and certification

ICH Q11/EDQM CEP/WHO pre-qualification

  • Selecting and justification for a starting material
  • Supply chain traceability
  • Responsibility of the API manufacturer
  • Responsibility of the pharmaceutical company
  • Impurities
  • Quality by Design (QbD)
  • Critical Quality Attributes (CQA’s)
  • API inspection/supplier audits
  • Lifecycle management/variations
  • Value and role of certification (EU/WHO)

Bioequivalence testing

  • EU new guidance
    • Basic principles
    • Design of studies
    • Pharmacokinetic parameters
    • Analytical considerations
    • Acceptance criteria
    • Biopharmaceutical Classification System (BCS)
    • Biowaivers – how to avoid the need for in-vivo studies
  • Relations and responsibilities of CRO/ pharmaceutical company
  • Supplier audits
  • Global bioequivalence requirements: WHO/EU/US
  • Lifecycle management/variations

Generic medicines

  • Overview of global requirements: WHO/EU/US
    • API requirements; known versus new substances
    • Pharmaceutical development
    • Bioavailability/bioequivalence
    • QbD
  • Lifecycle management/variations
  • Role of generic medicines in industrialised countries versus developing countries
  • Generic substitution
  • Falsified medicines

Course level:

TRNG

The Leadership Experience

Overview

LeaderPoint, in cooperation with DIA, conducts this comprehensive, three day management and leadership development program. This easy-to-understand course will provide learners with real-world training on applying interpersonal and leadership concepts to meet and exceed business goals.

Course Level: Intermediate/Advanced

Course level:

TRNG

Training Course for eCTD Submissions in Switzerland

Overview

Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will
offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD
submissions in Switzerland, and the eCTD review process. The focus will be on practical experience
gained in preparing and submitting eCTDs to Swissmedic.

Course level:

TRNG

US Regulatory Affairs

Overview

As drug development becomes a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information? This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes. This course will also enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members. Participants need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the US regulation of investigational new drugs (INDs) and biologics, of the basics of submission of applications seeking marketing approval for a product (NDA & BLA) and post-marketing regulatory requirements in the US.

Course level:

TRNG