The Application of Real-World Evidence in Regulatory Decision Making
Cerise James, MD, moderates this podcast in which Neil Belson, JD, discusses Real World Evidence and its impact to the biopharmaceutical industry.
Contemporary Applications of Real-World Evidence in Regulatory Decision Making: A Case Series Review
Real-World Evidence can show safety and effectiveness per FDA’s “totality of evidence approach” for evaluating regulatory submissions.
PODCAST: Medical Affairs Plans — From Strategic Planning to Measuring Impact
This Medical Affairs Professional Society (MAPS) podcast features medical affairs thought leaders offering insights into the Medical Affairs strategic planning process
Why Good Science is Good Business: A Conversation with Murali Gopal, MD
Murali Gopal, MD, discusses the power of Integrated Brand Planning to transform the Medical Affairs function within the biopharmaceutical industry
Eileen Sawyer: Big Reader, Science Nerd and Medical Affairs Leader in Gene Therapy
Sawyer is making it her life’s work to focus on the patient—the most important stakeholder in drug development.
The Future of Medical Affairs: A Conversation with Beat Sümegi, SVP Medical, Sanofi
MAPS speaks with Beat Sümegi, SVP Medical with Sanofi, about major areas of change and the need to help Medical Affairs professionals build new skills to succeed in this world of increased responsibility and opportunity.
Medical Affairs Improves Patient Outcomes Through External Medical Education
External medical education demands are continuously evolving, and MA needs to continue to evolve with these changes to establish effective education strategies.
Company-Led Education…What is in the Name?
What is company and medical affairs led education and how it is perceived by audience? What are the different perspectives existing among regulators, Pharma and agencies? What is the potential for disease state medical education by medical affairs?
Future-Proofing Your Medical Affairs Organization
OBJECTIVES: Identify the major trends and drivers towards digital transformation and drive Medical Affairs towards a digital future.
A Compelling Strategic Role for Medical Affairs in the Context of the new EU MedTech Regulations
This article provides an overview of the new MedTech European regulatory environment and opportunities for the Medical Affairs function to evolve and bring value to the respective organizations.