Every year since 2008, Health Network Communications organizes the World Drug Safety Congress to address drug safety and pharmacovigilance challenges. Join me this year in Chicago on April 23 and 24 where, on day one, I’ll be giving a presentation titled, “Safety and Reporting Requirements for INDs and BA/BE Studies.” I’ll be discussing important topics such as:
You’ve heard it a thousand times in our business: You’re not buying the service, you’re buying the people. I was fortunate enough to build our clinical team in Europe from the ground up, so I know better than anyone how true that statement is.
When I joined the organisation in 2008, I was the first European-based employee for UBC. I rented offices in a three-story, converted Victorian house in central London, which we still fondly refer to as the “old house,” and started seeking talented professionals to join me.
This week, I had the privilege of chairing the 4th Annual Pharmacovigilance & Risk Management Strategies Conference in Amsterdam, Netherlands. This event struck me as unique because the conversations were not theoretical; we had a room full of professionals who were able to speak from true, tested experience. We enjoyed debates throughout the day, exploring both sides of many issues with hands-on presenters who are actually working day-in and day-out within their areas of expertise.
Pharmaceutical manufacturers understand that systems supporting approval and marketing for their products must be designed and implemented with a global outlook. That’s easier said than done, taking into account the variety of regulatory bodies and requirements.
When developing a European Risk Minimization program, one size really doesn’t fit all. Manufacturers must consider that healthcare practices vary across Europe, leading to challenges in the implementation of risk minimization measures and effectiveness evaluation.