This is not a substantive post, just a note to say that I am visiting the RAPS Regulatory Convergence conference in Austin next week and then the Advamed MedTech conference in Chicago in the week after that.
I will speak about the emerging EU UDI policy at the RAPS Regulatory Convergence conference on Monday next week 3:30 to 5:00 pm in the session about UDI, Update & Lessons Learned. This will however be only one of the many interesting EU medical devices related presentations and sessions planned. There are many really good ones, with high profile speakers from notified bodies, the European Commission and industry, for example on:
- EU Enforcement of Existing Regulation: Unannounced Audits and Increased Oversight of Notified Bodies
- EU IVD Regulatory Evolutions
- Potential Impact of the EU Medical Device Regulation
- Impact of the New Proposed Regulations on Clinical Data Requirements in Europe
- Product Sampling During Unannounced Audits
Indeed, the RAPS conference is really a very good opportunity to catch up on EU medical devices developments.
The Advamed MedTech conference on 6-8 October will feature a panel moderated by me on the EU medical devices regulations revision process on Monday 6 October 2:30 pm in the International track, which should be very interesting with currently confirmed panelists:
- André-Michel Ballester, Chief Executive Officer, Sorin Group
- John Brennan, Director Regulations and Industrial Policy, Eucomed
- John Wilkinson, Director of Devices, Medicines and Healthcare Regulatory Agency (MHRA)
Since these panelists are as close to the EU process as you can possibly get, this should be a very interesting panel that you shouldn’t miss if you are interested in EU developments and are attending that conference. Last year’s EU panel was rated very well, and this year’s looks to be at least just as good.
Around the Advamed conference I will also be involved in the Dutch trade mission of companies supplying medical devices companies to Chicago – interesting too because the Dutch really know their materials science and are excellent at component design and production of complex components!
If you happen to attend these conferences and want to meet to catch up with me on whatever EU pharma, medical devices or ATMP issue that you want to discuss, please let me know in the comments to this blog or send me an email directly (erik.vollebregt[at]axonlawyers.com). I’ll be around at the conference venues for the full program at both conferences and am looking forward to meet many readers of this blog in person!