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Regulatory Webinar: The Science of Endpoints – Adaptive Pathways
December 14, 2017 @ 10:00 - 11:00 UTC+0
Who Should Attend?:
The webinar should be of interest to regulatory, clinical research, market access, and commercial staff.
Rory Graham, BPharm, MBA - Senior Director, Regulatory Affairs, Europe & International Region, Mapi (email@example.com)
Mr. Graham has facilitated numerous aspects of drug and medical device development during his 25 year career in the pharmaceutical, biotechnology and device industries. Mr Graham has held senior positions in the area of regulatory affairs in companies in Europe and Asia-Pacific. He has arranged and directly participated in meetings with many global agencies including FDA, EMA, PMDA, TGA and European National Agencies.
He has experience in various therapeutic areas including CNS, Oncology, Hematology, Immunology, Diabetes, Analgesia and Wound-Care. He has achieved orphan designations for pharmaceutical products in the EU, US and Australia. Mr Graham leads a talented team of regulatory professionals that produce client-specific regulatory and development strategies, as well as solutions for global and local market needs.
The adaptive pathways approach is part of the European Medicines Agency’s (EMA) efforts to improve the process of achieving early and progressive patient access to new medicines. Learn how the scientific concept of medicines development & data generation intends to address patients’ unmet medical needs using scientific endpoints during this upcoming event.
What the host intends to communicate during the webinar is:
- The background to the development of the Adaptive Pathways Initiative: what need is it designed to fulfil
- Comparative schemes with other regulators
- Acceptance Criteria for inclusion on the Adaptive Pathways scheme
- Outcome of the initial pilot scheme
- Multi-stakeholder engagement activities surrounding Adaptive Pathways
- Endpoint considerations in an iterative development model such as Adaptive Pathways.
- Expected benefits, outcomes and challenges from using the Adaptive Pathways scheme for patients, sponsors, regulators and payors.
The webinar will be of interest to those interested in obtaining an understanding of the Adaptive Pathways initiative and where it sits in todays’ regulatory paradigm. It will help potential sponsors to consider whether their product is eligible for, and indeed if it is desirable for them to pursue, the Adaptive Pathways scheme.
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