Last week, more than 100 senior Late Phase pharmaceutical professionals and key opinion leaders representing Medical and Scientific Affairs, Health Economics and Outcomes Research, Safety and Risk Management, Regulatory, Market Access and Drug Reimbursement met in Berlin, Germany, at the Third Annual Medical Affairs Leaders Forum.
The convergence of payer and regulator evidence requirements warrants a strategic evidence generation plan and a mindful orchestration of peri and postapproval real-world studies. Study designs resulting in a diverse array of health economic and safety data are increasingly warranted to meet the demands of various stakeholders.
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.
The past twelve months have brought change, and with it, new opportunity. In our last blog post of 2013, we want to take a moment to reflect on our accomplishments and share with our readers some highlights from this past year:
ISPOR 16th Annual European Congress, held November 2-6 in Dublin, was a great success, providing the opportunity for thought-provoking presentations as well as valuable networking and information sharing.
Industry thought leaders participated in a panel that explored patient-reported outcomes and how best to incorporate them in EMA and FDA safety mandates. Additionally, our UBC experts presented a number of abstracts throughout the conferences.
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.