9th September 2019
9:00 – 10.30am - Interactive presentation
10:30 – 11:00am - Networking break
11:00 – 12:30pm - Interactive presentation and Discussion
Observational studies using real-world evidence (RWE) provide significant opportunities to gain insight into treatment patterns and outcomes in clinical practice outside randomized controlled trials. RWE is being widely used to gain an understanding of disease epidemiology, patient journey, real-world use and effectiveness of treatment options, unmet patient needs and the value that products offer in sub-populations. In this workshop, you will learn the opportunities and benefits of RWE.
WHO IS IT FOR?
This workshop is ideal for anyone who wishes to become familiar with key issues in the areas of real-world evidence. It is particularly relevant to individuals working for Pharma/Biotech companies, regulatory authorities, HTA bodies, patient organizations, consultancy and academic institutions.
Femida Gwadry - Sridhar, CEO & Founder
Joe Ternullo, Head, Business Development
13.30 - EAP Perceptions, fears, hopes & knowledge
14.00 - Case-study- GENE THERAPY MAP
14.15 - Introduction to MAP - Regulatory overview and patient and HCP perspective.
15.00 - Break
15.30 - Case-study - Global CNS MAP
15.45 - Implementing a MAP
16.30 - Case-study - GLOBAL Oncology MAP
16.45 - How we go forward
This interactive presentation will provide you with an opportunity to learn more about how EAP’s provide pre -launch access for drugs in advance of their Marketing Authorization (MA) for patients with life-threatening conditions and no approved treatment options. Best practices in EAP planning, Set-Up and management, and provide information on current regulatory changes.
WHO IS IT FOR?
This workshop will be extremely beneficial to those individuals considering an EAP as part of their drug development strategy. Project Managers and Executives in Pharma/Biotech/Advocacy interested in knowing how to set-up an Early Access Program.
Robert Donnell, Head of Business Development
Supported by: Dan Piggott / Todd Galles