May 12, 2021 - May 13, 2021
Date: May 12th and 13th, 2021 (There are also activities on May 6th and May 10th)
Time: 10.00 AM - 2:00 PM
Qserve's Attendees: Gert Bos and Lorry Weaver
At FDA/Xavier PharmaLink, we work to find solutions that will increase confidence in your product quality throughout your global supply chain. We do this by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond our industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization and our industry.
Wednesday, May 12th
Gert Bos (Moderator) 10:10 AM - 11:10 AM Impact Approvals by Strengthening Your Core Technical Documentation
In accordance with Regulation (EU) 2017/745 on medical devices, the technical documentation referred to in Annex II and Annex III must be compiled and maintained for each medical device. What are the exact differences to the current directives or the internationally recognized STED (GHTF/IMDRF) format? Which elements need to be prioritized in order to implement an efficient and risk-based planning for the transfer of an existing MDD-compliant technical documentation? Unfinished concepts, such as harmonized standards or common specifications, are making it even more difficult, because the release is still pending and there is still no clear statement about the timing. And above all, how will you manage to get all of the information to be consistent throughout a dossier, and even between dossiers on different products in your portfolio. This training will present you important considerations for implementation planning, including prioritization and critical elements outline.
Gert Bos (Speaker) 12:50 PM - 1.50 PM Putting Together the Pieces of Constantly Changing Global Regulatory Requirements
How does your organization manage the evolving medical device regulatory environment? Are you struggling to keep up with how to meet new or changing regulatory requirements throughout the world? Join medical device industry experts for a panel discussion where you will learn about best practices in the management of applicable regulatory requirements. These representatives will provide examples of ways they are addressing requirements outside of the US and EU.
Thursday, May 13th
Gert Bos (Moderator) and Lorry Weaver (Speaker) 11:05 AM - 11.55 AM Status of EU MDR and EU IVDR Implementation and Lessons Learned
This interactive session will enhance your ability to plan for and manage the many uncertainties in the EU MDR/IVDR. Although the basics are clear, and guidance on the structure and underlying support systems have been created, the interpretation of intent and how to meet the intended expectations are not clear. Join this session to understand the evolving landscape and be confident that you know what is required to be in compliance. With the implementing guidance continuing to be released, we will explore how to successfully address the challenges of interpreting the details.
For more information about the Conference and to register, please visit the event website.