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Tuesday, 14 December 2021 (10:00 AM) - Wednesday, 15 December 2021 (4:00 PM) Central European Time
Getting more clinical data has been talked about in Europe for a decade now, since the talks started on the ‘recast’, ultimately culminating in the MDR that is rapidly getting into full force. One of the core reasons behind the legislative update was to reinforce the rules on clinical evidence and strengthening of post market surveillance requirements for manufacturers. After having ignored the issue for a few years, many manufacturers moved to schedule large clinical trials, only to get to a realization that this could turn out to be unaffordable, and products would have to be removed from the EU market. In recent years the search has focused on the middle ground: finding cost effective ways and tools to create clinical data, and alternatively to just collect clinical data and turn them into clinical evidence. This workshop will guide you trough the benefit and pitfalls encountered in this middle road to clinical safety.
28 June 2021 –14 November 2021: Early Bird Member €660 | Nonmember €740
15 November 2021 - 15 December 2021: Regular Member €740 | Nonmember €825
Learning objectives:
- PMCF. Understanding its aim under MDR and options for doing PMCF with their related value
- IIS/IIT were common under MDD. Pros and cons and the valuable under MDR
- ISO14155 GCP. The role and value of GCP. GCP compliance in practice. Consequences of incompliance
- Strategy and planning not to be underestimated. Focus is often too early on operational parts without good considerations.
- Sites and site relationships to be build and maintained.
- Electronic data capture (EDC) and absolute must.
Gert W. Bos, FRAPS, President of RAPS CSO Qserve Group
Gert is an expert in European regulations based on 18 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic consultant. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultant with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president of RAPS, and serves as board member of RAPS Europe.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.
If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.