Receive $100 off of your DIA 2018 Meeting registration by registering for two half-day short courses or one full-day short course. Purchases must be made at the same time in order to receive the discount.
Short Courses are designed to enhance your knowledge in a broad or specific area for your day-to-day job function. Short Courses are an additional fee to the meeting registration cost.
The ICH E14 guidance requires pharmaceutical companies to conduct Thorough QT (TQT) studies to evaluate a new drug's cardiac safety.
The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished.
This course will review regulatory precedent (and the pathway to locate, assess, and integrate) as a global regulatory strategic driver.
Recent clinical trial transparency regulations have been developed to provide greater access to clinical trial information.
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 with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting.
This course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates.
R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development LifecycleJune 24 | 8:30AM-12:00PM
Quality oversight of drugs throughout the product development lifecycle is complex, crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way.
Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?June 24 | 8:30AM-12:00PM
Real world evidence (RWE) has the potential to compliment and extend the safety and effectiveness knowledge of drugs gained from RCTs. This session will discuss key study design principles to guide evaluation of RWE using studies focused on cardiovascular safety assessments.
The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology AssessmentJune 24 | 8:30AM-12:00PM
Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines.
The Identification of Medicinal Products (IDMP) is a new industry regulation that pharmaceutical, biologics, and generic companies must comply with in the EU. The main objective of IDMP is to provide the basis for a unique identification of medicinal products. EMA is the first competent authority that has mandated the implementation of IDMP, and other regions (including the US and Japan) are expected to provide their deadlines in the near future.
Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues.
TransCelerate Biopharma, Inc. is a nonprofit with membership of 19 biopharmaceutical companies coming together to improve the clinical development process. TransCelerate first issued the Common Protocol Template (CPT) in 2015, and since has seen more than 3,700 download of CPT assets, including the Technical-Enabled Edition of the CPT, a free, MSWord-based template, and add-ins to enable protocol authoring and use of the CPT.
In this case study the audience will serve as the CDER Cardiorenal Advisory Committee voting on the same questions as on September 2011 (Rivaroxaban for stroke prevention in atrial fibrillation). The case-study will follow the following sequence: CDER Advisory Committee structure and function relative to CDER decisions, rivaroxaban pivotal trial summary (Rocket AF), critical video clips from the advisory committee impacting your vote, biostatistics analysis discussion, your vote, and post advisory committee history including realizing the portable device used to measure INR malfunctioned.
Participants will learn how to utilize the ‘Single Place of Truth’ for cross functional collaboration, improving business transparency and information exchange of regulatory data across the enterprise, achieving Regulatory Information Excellence during medicinal product lifecycle.
The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets.
Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical DevelopmentJune 24 | 1:00-4:30PM
Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation, and J-NDA preparation and review.
This short course will explore machine learning (ML) and its application within the Regulatory/ Pharmacovigilance (PV) landscape. We will provide a high-level introduction to ML, including tools and project tips. The core of the course will dive deeper into applications within PV, including examples from our work on ICSR identification. We will also discuss what the future of ML in PV could look like, followed by time for questions and open discussion.
Since machine learning requires resources from across the organization, this course is designed for anyone interested in sponsoring or joining a machine learning project within their organization.
Are you ready for ICH E6 (R2)? Have you defined your Quality Tolerance Limits? This highly interactive short course with hands-on experience will apply the TransCelerate Issue Management Conceptual Framework as a foundation in setting tolerance limits, managing issues, and applying analytics as part of quality risk management.
Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative TherapiesJune 24 | 1:00-4:30PM
Duane Schulthess, Managing Director of Vital Transformation, and Luca Pani, former Director General of the Italian Medicine's Agency and currently a Faculty Member at the University of Miami, will run a short course outlining how best to harness RWE to better understand the price, value, and impact of next generation therapies.
As technology advances, so do opportunities for combining different technologies to solve some of the world’s most pressing medical issues. The lines between engineering, chemistry, and advanced biologic processes are becoming blurred – the age of combination products is here.
Data integrity – along with human research subject protection – have long been primary quality objectives of clinical research. With the advancement of technology and science in human research, regulatory agency’s focus on data integrity has intensified. GCP enforcements, such as 483's, Warning Letters, Notices of Concern, and EU inspections continue to escalate and describing the impact of noncompliance and risk to data integrity.
ICH E6 R2 states it loud and clear - “the scale, complexity, and cost of clinical trials have increased. Evolution in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities.” Time to revise your audit strategy! Join us as we develop audit plans that address quality in a targeted, efficient, nimble, calculated, and risk-based manner. Learn to use technology to circumvent governmental travel advisories, weather hazards, resource limitations (auditors, time, and budget), etc., without sacrificing audit goals. Garner the experience and expertise of department heads from Data Management, Clinical Operations, Information Technology, etc,. to fulfill technical assessment/oversight requirements. A wide range of audit types [vendor qualification/re-assessment (CROs, pharmacovigilance, eCOA vendors, etc.), investigator sites, internal process audits (when the department is off-site), trial master files, GLP, etc.] will be discussed.