SCHEDULE | FRIDAY, JULY 13TH
8:00 REGISTRATION & WELCOME COFFEE
8:45 CHAIRPERSON’S OPENING REMARKS
9:00 KEYNOTE ADDRESS: IVDR TIMELINES & IMPACT ON MANUFACTURERS AND ECONOMIC OPERATORS THROUGHOUT THE SUPPLY CHAIN
- Fundamental changes required under the IVDR
- Primary timelines & deadlines of importance
- Impact on new products vs. certified IVDs
- Requirements for supply chain partners
- Potential modifications in light of Brexit
Dr. Andreas F. Stange, Vice President MHS global IVD, TÜV SÜD
Vipul Rathore, PhD, Auditor, Product Specialist, TÜV SÜD AMERICA
10:30 COFFEE & NETWORKING BREAK
10:45 RECOGNIZING FUNDAMENTAL CHANGES IN DIAGNOSTIC REGULATIONS: CLASSIFICATION & CONFORMITY ASSESSMENT
- Discussion and analysis of IVDDs evolution to IVDR
- Responsibilities for competent authorities & economic operators
- Exploring IVDR aligned/equivalence with FDA regulations
- Companion diagnostics definition, requirements, and timelines
Haijuan (Jane) Li, PhD, MBA, RAC, Project Manager (IVD Expert), DEKRA CERTIFICATION, INC.
11:30 STATUS UPDATE ON NOTIFIED BODY DESIGNATION AND IVD CERTIFICATION
The IVDR not only implements new requirements for manufacturers, but also contains significant policy and process changes for notified bodies who are responsible for certifying and auditing diagnostic products. Under the IVDR, notified bodies must establish enhanced quality management systems, demonstrate greater technical expertise, and were required to re-apply for designation in November of 2017. These new requirements have limited the number of notified bodies available to manufacturers significantly, leaving IVD companies concerned.
- Updates on re-designation, capabilities and timelines
- Tips for selection, qualification and management
- Proactive measures in case of notified body orphanage
Erik Vollebregt, Partner, AXON LAWYERS
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 INDUSTRY PANEL DISCUSSION: OBTAINING CORPORATE SUPPORT AND AWARENESS ON IVDR TRANSITION
US based regulatory professionals have the arduous task of educating corporate executives on the broad impact of EU regulatory initiatives, which will affect any product with a CE marking. The new regulations require increased internal resources including staffing, budgeting and training to conduct gap analysis and remediation. While May of 2022 may be a few years away, it is critical for IVDR manufacturers to quickly obtain corporate consent and support for implementation and ongoing support.
- Tools to educate and illustrate IVDR affects company-wide
- Comprehensive approaches for obtaining necessary resources
- Crafting transition scenarios & dependencies to mitigate risks
Mike Benecky, Sr. Director, Global Regulatory Affairs, Precision and Digital Medicine, GLAXOSMITHKLINE
Laura Caltagirone, Director of Quality Assurance and Regulatory Affairs- Management Representative, ALCOR SCIENTIFIC
2:15 MASTER CLASS: TECHNICAL FILE CONSTRUCTION AND DOCUMENTATION – PERFORMING GAP ANALYSIS ON EXISTING FILES
The EU IVD classification system has been completely overhauled under the IVDR, migrating from a list-based classification system to a risk-based framework, which is aligned with the on International Medical Device Regulators Forum (IMDRF) rules. This change will likely impact all IVDs on the market, as manufacturers will need to reclassify each device pursuant to the new classification system and update their technical files accordingly. Thorough consideration and planning will aid in establishing the required technical documentation and maintaining the file.
- Integrating new provisions into existing strategy
- Practical aspects of updating documentation
- Application of existing documentation and data
- Life cycle management: compilation and testing
Julien Senac, Ph.D., Certification Project Manager, LNE/G-MED NORTH AMERICA, INC.
3:15 COFFEE & NETWORKING BREAK
3:30 UNDERSTANDING NEW POST-MARKET SURVEILLANCE AND VIGILANCE REQUIREMENTS FOR IVDR
With a greater emphasis on post market surveillance activities for CE marked products, the IVDR provides detailed guidance outlining manufacturer’s roles and responsibilities. IVD manufacturers must now develop a strategy which incorporates both a proactive and reactive approach to systematically collecting and analyzing relevant data pertinent to the quality, performance and safety of the device through the entire lifecycle of a marketed diagnostic. Practical insight into peer’s experience in conducting a thorough PMS strategy revision will enable participants with valuable advice and ideas to competently achieve the transition.
- Fulfilling PMS IVDR requirements
- PMS System, PMS Plan, PMS Report & PSUR
- PMS that necessitates additional clinical studies
Erik Vollebregt, Partner, AXON LAWYERS
4:30 CLOSING REMARKS & WORKSHOP CONCLUSION