pharmasol was a proud sponsor of the GERMAN PHARMACOVIGILANCE DAY in Frankfurt.
Our Chief Quality Officer, Marc Zittartz, talked about the rise of Medical Device / Pharmaceutical combination products and the challenges this brings to pharmacovigilance. He shares some thoughts here on the rest of the day….
There were several excellent presentations from other speakers. I would like to highlight the following:
Dr. Thiele, now retired from BfArM, gave some insights into the workings of the Pharmacovigilance Risk Assessment Committee and the processes and different committees involved until the European Commission comes to a decision. Very interesting were his views on the current proposal of having public hearings in the context of his experience of organizing similar public hearings in Germany some years ago. If you ever have the chance to attend a conference with Dr. Thiele as a speaker, I highly recommend it.
Dr. Runge, a lawyer, gave his opinion on legal pitfalls in PV. As people working in pharmacovigilance usually have a medicinal or natural sciences background it was very interesting to learn how a lawyer reads and interprets the regulatory guidelines. A particularly interesting item was the question on who is responsible and liable for the content of Risk Management Plan (RMP) summaries that the EMA publishes. While the pharmaceutical company writes the RMP, it is reviewed by the PRAC and approved by the CHMP, and then the EMA write a summary. Who is liable for the RMP summary? This question will probably be resolved in court in the future.
You can see Marc’s presentation here: The Rise of the Medical Device/Pharmaceutical Product combination and how it affects traditional Pharmacovigilance