In-Person

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in the application of adaptive designs in the pharmaceutical industry, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010.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

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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

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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.

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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).

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Overview

This course provides a comprehensive framework on benefit-risk of medicinal products. Participants will learn about the principles, legal, and regulatory basis for benefit-risk obligations and frameworks for compliance. Fundamentals of benefit-risk assessment will be covered, including methods commonly used and incorporation of the patient perspective. Participants will be able to apply the key concepts learned to conduct a benefit-risk assessment and select tools to optimize benefit-risk balance. 

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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

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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

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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

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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

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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.

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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

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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

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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

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Overview

Good writing begins with good planning, whether you are at the beginning of clinical development or working on an approved medicine. In recent years, there has been an increasing demand for regulatory documents focusing on patient safety. The requirements for safety reporting are similar worldwide and share the necessity for the writer to effectively distill the risk and benefits of the medicinal product. To successfully manage these reports, safety medical writers must be able to understand the principal scope of the pharmacovigilance (PV) documents that are relevant during the medicinal product lifecycle. Equally important to delivering a succinct summary is effective collaboration with safety professionals, which requires special consideration and analysis of the data to clearly communicate the key messages and findings for a given report.

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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.

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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

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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

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

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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

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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. 

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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

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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

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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

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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.

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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

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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

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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.

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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

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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.

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Overview

Quality of PSURs and PBRERs became a major compliance issue globally, as the complexity of the documents increased hand in hand with unprecedented level of regulatory scrutiny and attention.
This practical training course will help industry professionals to keep up with the new demands. It introduces essential aspects of medical writing of aggregate safety reports (PSURs and PBRERs) in the context of current legal framework in the EU and globally.
Course participants will learn all they need to know about the requirements set out in the ICH E2C(R2) (plus Q&A) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) - Module VII, as well as global acceptability and local variability in the requirements.
Course will demonstrate best practices in source data collection, about the essential role of quality checks (QC) during the whole process of report preparation, and about critical aspects of medical writing, including data editing and presentation.
A practical exercise involving key aspects of the medical writing process, based on real-life examples, will be included.
Participants will be provided with preparatory material to allow for maximum benefit from the team exercises onsite.

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Overview

The regulations surrounding Chemistry, Manufacturing, and Controls (CMC) can often seem daunting and challenging.  However, with the proper training and knowing where to look amongst the FDA regulations and other important resources, you can become an informed and knowledgeable regulator that can tackle CMC issues.   This course has been assembled for the beginner in CMC as well as the intermediate CMC professional who is looking for a refresher course in several facets of CMC.  This interactive course will allow you to apply several of the principals learned to real life situations to arm yourself with the tools to write and/or assemble CMC sections of regulatory submissions, prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding on how to avoid noncompliance.

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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

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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

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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

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Overview

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

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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

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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

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Overview

An important part of any project is having a risk management plan in place. This course will identify what include in the plan as well as review the tools and techniques that can be applied. 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.

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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

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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

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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.

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This course provides an introduction to the science of risk communication for medicinal products, the relevant regulatory context in the US and EU, the basics of risk communication in product risk management, and new directions in the field, including the use of digital and other eHealth methods and patient-centered approaches to risk communication.  The course curriculum is directed at basic- through intermediate-level professionals who seek a greater understanding of the vital role of risk communication in medicinal product benefit-risk assessment, risk management and therapeutic treatment decision-making across the product lifecycle.  Learning approaches will feature a mix of instructional sessions; real-world case studies; and applied, interactive, individual and small-group learning exercises.

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Overview

This training course is focused on the strategic and operational aspects of global safety risk management. Key concepts, principles, and tools necessary to develop risk management programs will be introduced. Participants will be exposed to the regulatory requirements in the US and European Economic Areas (EEA). Through interactive case studies, learners will engage in exercises to apply the knowledge gained from instructional sessions.

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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.

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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

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Overview

This training course will describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System. The topics will cover organizational structure, responsibilities, processes and resources required for the pharmacovigilance (PV) system and its quality system. The course is designed for the intermediate level professional and employs a mixture of informative instructional sessions, real-world case studies, and hands-on interactive exercises where attendees can apply what they learn. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.

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