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Join NAMSA for the Virtual RAPS Convergence 2020

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Date/Time

Date(s) - September 13, 2020 - September 16, 2020 All Day

NAMSA invites you to join us at the virtual RAPS Convergence 2020 on September 13-16. This regulatory event is one of the largest annual gatherings of regulatory professionals, regulators, scientists, and innovators from around the world.

This year, the regulatory community will converge online with two virtual registration options that will allow attendees to experience the RAPS Convergence live online from the safety and comfort of their homes. With this new online format, any sessions you are unable to attend live can be viewed on-demand at your convenience.

Join NAMSA for our educational sessions listed below and visit us at our virtual booth at Booth #306.

Complimentary 30-minute consultations with NAMSA’s regulatory experts will also be available through virtual chats and phone calls. We welcome the opportunity to discuss with you the most cost-effective regulatory pathway to market based on your unique product development requirements.

Video Chat Schedule

  • Sunday, September 13 (1:30-2:00 PM)
  • Monday, September 14 (11:30 AM-12:00 PM)
  • Monday, September 14 (1:30-2:05 PM)
  • Tuesday, September 15 (10:30-11:00 AM)
  • Tuesday, September 15 (12:30-1:00 PM)
  • Wednesday, September 16 (11:30-12:05 PM)

NAMSA Educational Sessions

September 14, 2020 | 12:00-1:30 PM ET

Implementing Effective EU MDR Postmarket Surveillance (PMS) Processes to Deliver Your Periodic Safety Update Report (PSUR): Challenges and Practical Approaches

Session Leader: Adrian Keene, BSc (Hons); Director EMEA, Consulting Services

The introduction of the EU MDR brings greatly increased ongoing Post-Market Surveillance (PMS) expectations for both manufacturers and economic operators. Articles 83-86 and Annex III detail the requirements, but without defining the expectations to be fully compliant. It is often difficult for manufacturers to translate their existing PMS data and processes into the more rigorous framework of the EU MDR. Creating a pragmatic process that fulfils requirements whilst not becoming overly burdensome is critical to the ongoing success of the PMS system.

This session will address the practical aspects of setting up an effective PMS plan, considering the requirements and methods tailored appropriately to class and nature of the device. Selecting sources of data to set and monitor suitable indicators and threshold values will be addressed, as well as effective trend reporting and monitoring. The output of the PMS process is the PSUR (article 86) or post-market surveillance report (Article 85), which supports the ongoing risk/benefit assessment, and becomes an integral part of continued compliance to the MDR. Information is drawn together from many sources, including risk management, post market clinical follow-up (PMCF), vigilance, trend reporting and clinical evaluation. To implement a practical process to prepare these documents the inter-relationship between the relevant processes needs to be understood. We will address the practical execution of the PSUR process, considering timelines to gather data from relevant sources, and providing a meaningful output for both manufacturers and regulators. Potential challenges and pitfalls will be considered.

Learning Objectives:

– Demonstrate their understanding of the key concepts and requirements of PMS and its outputs.

– Interpret the principles discussed and apply them practically within their organization to create pragmatic solutions to meet PMS/PSUR requirements.

– Review their organization’s current PMS processes to address this need and amend them to create pragmatic solutions to meet the requirements.

September 14, 2020 | 12:00-1:30 PM ET

Transitioning From the Soft Transition: Technical Documentation and UDI

Session Speaker: Jane Arnold-Round; Principal Regulatory Consultant

Most medical device manufacturers have elected to renew their MDD/AIMD CE certificates early to take full advantage of the soft transition. By doing this manufacturers were able to delay when the technical documentation had to be updated. This strategic delay provides an opportunity to learn from the experience of others, however manufacturers must not wait to long. The required changes to the technical documentation to demonstrate compliance to the MDR is not a simple compilation or reformatting exercise. Manufacturers must plan adequate time and resources to ensure the technical documentation updates are compliant to the MDR and have a submission strategy that avoids the anticipated bottleneck of submissions leading up to 26 May 2024.

During this session the time and resources required to update technical documentation for low risk simple devices and high risk complex devices will be discussed. Speakers will describe to attendees the challenges and roadblocks that were encountered, and any lessons learned. A Notified Body reviewer will share experiences during the review of MDR technical documentation, share common non-compliant areas and discuss the anticipated best time to submit.

Learning Objectives:

– Create a strategy for the required start and completion of MDR technical documentation updates.

– Describe, anticipate and avoid potential challenges and non-compliance.

Speaker

Adrian Keene, BSc (Hons)

Director EMEA, Consulting Services

With 26 years of experience in the medical device industry, Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. His current responsibilities at NAMSA involve regulatory, quality, biological evaluation and medical writing—working with a broad range of devices including drug-device combination products.

Prior to working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS. Before working with the notified body, he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Device Directive (MDD).

Jane Arnold-Round

Principal Regulatory Consultant

Jane Arnold-Round has over 25 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations from start-ups to multinationals. She worked as a Notified Body reviewer for over 15 years at BSI as a Medical Device Product Specialist with particular responsibility in the wound-care sector. Prior to joining NAMSA in 2018, she was a Regulatory Consultant for 14 years. Jane’s current focus involves complex submissions for high-risk devices, including development of regulatory and clinical strategies, design dossier and technical file compilations, device-drug consultations, clinical evaluations and regulatory due diligence.