Conference Agenda
Pre-Conference Workshop
Monday 16th March 2020
Workshop A:
Opportunity for Real-World Evidence in Improving Patient Outcomes
AGENDA
9:00 – 10.30am - Interactive presentation
10:30 – 11:00am - Networking break
11:00 – 12:30pm - Interactive presentation and Discussion
ABOUT
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.
Workshop B:
Successful application to global market access for orphan drug therapies
AGENDA
9:00 – 10.30am - Interactive presentation
10:30 – 11:00am - Networking break
11:00 – 12:30pm - Interactive presentation and Discussion
ABOUT
Learn more about how can manufacturer meet global patient demand for access to medicines prior to approval. This will also discuss some of the methods that orphan drug manufacturers can do to partner with governments to bring orphan drugs to the market. R&D strategies to be implemented to accelerate market access for orphan drugs will also be explore. And how can patient, governments and orphan drug companies help support each other’s initiative to provide market access to patients?
WHO IS IT FOR?
This workshop will be extremely beneficial to those individuals involve in development, commercialization and market access of orphan drugs. Project Managers and Executives in Pharma/Biotech companies, consultancy, Patient Advocacy, interested in knowing how to successfully launch an orphan drug.
Managed Access/Early Access Programme
ABOUT
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.
AGENDA
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
- Functions - Considerations
- Timings - Charging
- Costs
16.30 - Case – study – GLOBAL Oncology MAP
16.45 - How we go forward
Presenter:
Robert Donnell, Head of Business Development
Supported by: Dan Piggott / Todd Galles