DAY ONE | WEDNESDAY, DECEMBER 4
8:00 REGISTRATION & WELCOME COFFEE
8:45 CHAIRPERSON’S OPENING REMARKS
9:00 OPENING ICE BREAKER: SHARING LESSONS LEARNED IN ALIGNMENT OF QMS WITH MDR & IVDR
The interactive ice breaker will open the event with an opportunity for participants to move around the room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange 2 important lessons learned thus far within steps taken to transition QMS compliance to MDR or IVDR requirements. Participants in this warm-up session are also given the opportunity to build contacts with industry peers, kicking off the event networking platform.
9:20 ROUNDTABLE: UNVEILING NOTIFIED BODY PERSPECTIVES IN UPDATED & NEW QUALITY REQUIREMENTS
As the device and diagnostic industries continue to prepare quality management systems for compliance with the new regulations, lingering questions and areas of uncertainty persist. From technical file content to proactive post-market surveillance and QMS data management, clarification is needed from notified bodies to ensure relevant measures are applied in due time. This interview session led by an industry representative will enable the audience to address spe¬cific questions to notified bodies, with the aim of shedding light into timely and helpful information, all while clarifying areas of divergence among regulators.
MODERATOR: Marta Carnielli, IVD Technical Officer, TÜV SÜD
Sabine Ohse, Head of Notified Body IVD, MDC – MEDICAL DEVICE CERTIFICATION
Michael Bothe, Co-Head of Certification Body Active Medical Devices, DQS MEDIZINPRODUKTE
10:20 COFFEE & NETWORKING BREAK
10:45 INDUSTRY-SPECIFIC SMALL GROUP DISCUSSIONS: ACHIEVING A UDI SYSTEM ENCOMPASSING EU REQUIREMENTS
While medical technology manufacturers are familiar with UDI rules for the US market among others, requirements within the MDR and IVDR differ and introduce new areas of focus. Medical device and higher class IVD quality professionals are in the process of revising existing strategies to incorporate MDR provisions without developing a distinct process in order to contain costs and ultimately streamline operations, while lower risk IVD professionals with up-classified products are in the midst of developing a traceability strategy for the first time. Participants in this session are given the opportunity to gather and exchange with peers from the same industry to share challenges and solutions in the implementation of EU UDI compliance through focused small group discussions led by knowledgeable facilitators.
Benjamin Kaufhold, Quality Management & Regulatory Affairs, BOSCH HEALTHCARE
11:30 MASTERCLASS: ENHANCING ECONOMIC OPERATOR MANAGEMENT & STRENGTHENING SUPPLIER CONTROL
The MDR and IVDR introduce new definitions and roles for all stakeholders involved in the medical technology supply chain, with the goal of ensuring increased safety for the end-user. The scope extends to additional responsibilities focused on vigilance and regulatory compliance verification, incumbent to importer and distributor partners and impacting existing contracts. In addition, much focus is set on enhancing supplier control and supervision in order to have full visibility on 3rd party quality systems and manufacturing processes.
PART 1 – OVERVIEW OF ECONOMIC OPERATOR REQUIREMENTS
- MDR/IVDR definition of economic operators
- Mapping a comprehensive supply chain
- Revising partnerships & contracts
- Quality checks & compliance verification
Mayda López-Belmonte, Director Quality & Regulatory Compliance Spain, and Innovation EMEA
JOHNSON & JOHNSON
12:00 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:15 PART 2 – PANEL DISCUSSION: REVISED SUPPLY CHAIN STRATEGY COMPLETION
- Implementing supply chain verification with partners
- Vigilance & complaint handling processing concerns
- Limits in the training & management of partners
- Small vs. large company: Differences in strategies
Matthias Bürger, ZIMMER BIOMET
Mayda López-Belmonte, JOHNSON & JOHNSON
Isabelle Kohlstetter, CARDINAL HEALTH
2:00 PART 3 – SMALL GROUP DISCUSSION: SOLIDIFYING SUPPLIER EVALUATION & CONTROL
To fulfill stringent MDR and IVDR requirements and obtain full visibility into a supplier’s quality system, direct auditing of suppliers’ manufacturing sites is considered most efficient. However, the time and cost involved prove challenging for many organizations, particularly midsized and small. This small group discussion divided by industry and company size, focuses on peer-to-peer sharing to give the audience a unique opportunity to exchange strategies for better control of suppliers, and debate best practices within each industry.
Melissa Finocchio, Sr. Director, Global Quality – Business & Support, BIOMERIEUX
Martin Geertsema, EMEA Director, Quality Assurance & Regulatory Affairs, CONMED
3:00 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE: ROLE & INVOLVEMENT IN QUALITY MANAGEMENT
- PRRC’s exact role within the organization & quality team
- Incumbent responsibilities & extent of liability considerations
- Lessons learned from the Qualified Person role in pharma
- Portraying & identifying the ideal candidate for the position
Erik Vollebregt, Partner, AXON LAWYERS
3:30 COFFEE & NETWORKING BREAK
4:00 BRIDGING CLINICAL & QUALITY TO MASTER CLINICAL ASPECTS OF THE QMS
With a strongly enhanced focus on risk mitigation and management for the end-user, the MDR and IVDR demand for accentuated attention to be set on clinical testing both in the pre and post-market phases. The clinical evaluation plan, including post-market clinical follow-up, as an integral component of quality management as well as post-market surveillance and vigilance measures, must now be fully understood by quality professionals in order to demonstrate compliance in the case of an audit without relying on clinical teams. It is therefore critical to enable further clinical knowledge into quality professionals via proper training and transparent communication between both teams, and ultimately move away from siloed organizational structures.
- Partnering with clinical to enhance risk management
- Clinical training curriculum for quality professionals
- Efficiently balancing clinical knowledge transmission
- Enabling quality teams to explain the PMCF plan
Yana Pozhidaeva, Associate Director, Clinical Quality Assurance, ABBOTT
4:30 INDUSTRY-SPECIFIC SMALL GROUP DISCUSSIONS: SHARING SOLUTIONS TO TIMELY MDR/IVDR COMPLIANCE CHALLENGES
While the medical device and diagnostic industries face different timeframes for compliance with respective regulations, necessary action must swiftly be taken to bring the regulatory transition to completion by the deadlines. Quality professionals continue to address pressing challenges and aim to organize final steps in a practicable manner in order to ensure new and updated provisions are implemented. This peer-to-peer discussion format, led by knowledgeable moderators enables participants to gather in small groups divided by industry, to identify and dive deeper into specific areas of concern for each delegate, and brainstorm solutions to problems raised all while sharing strategies from individuals’ experience.
- Group 1 – Medical Devices:
Wolfgang Werner, Senior VP Regulatory & Quality, BIOVOTION
Genevieve Michaux, Partner, KING & SPALDING LLP
- Group 2 – IVDs:
David Lansbergen, Manager Regulatory Affairs & Quality, EMEA, SAKURA FINETEK EUROPE
Laure Le Calvé, Managing Partner, LCH
5:30 CLOSING REMARKS & DAY 1 CONCLUSION
6:15 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on December 4th. Please note that dinner expenses must be covered by each participant individually.