Regulatory Webinar: The Science of Endpoints – Adaptive Pathways
December 14 @ 10:00 - 11:00 UTC+0
Who Should Attend?:
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.
Presentation Topic Details:
The adaptive pathways approach is part of the European Medicines Agency’s (EMA) efforts to improve timely access for patients to new medicines. Adaptive pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine. The approach makes use of the existing European Union (EU) regulatory framework for medicines.
Learn more during this upcoming webinar!
Register to Attend: