Risk Management Workshop

THIS WORKSHOP IS SOLD OUT

Description: As Manufacturers adapt to the requirements of EU MDR/IVDR, there is a need to understand the linkage of Risk Management to all processes throughout the product lifecycle. Many companies are struggling to fully understand the requirements and find a pragmatic approach to implementation. While EU MDR/IVDR reinforces many of the practices and norms from ISO 14971:2019 and aligns well with it, it also emphasizes a few key points, such as:
- Linkage to Clinical Plans, CER/PER, SSCP/SSP, PMS Plans, PSUR/PMS Report, PMCF as well as design V&V, process validation and labeling;
- Inclusion of Combination Products (medical devices and medicinal products as a single integral product)
- Specific requirements in the PMS Plan (Annex III) and CEP (Annex XIV) which allude to quantitative risk management (e.g. "indicators and thresholds for benefit-risk")
- Connection of risk-acceptability criteria to pre-market data and post-market information in a meaningful way; and
- Disclosure of residual risk

This workshop will discuss linkage of risk management to other processes and will demonstrate how it can be utilized throughout the product lifecycle. Participants will learn how to create risk management documentation that links to clinical evaluation, supply chain operations and post-market data by participating in a hands-on case study.

Agenda
8:30-8:45 Welcome / Workshop Introduction – Review Agenda and Objectives
8:45-9:30 Lecture – ISO 14971, EU MDR/IVDR Risk Management Requirements
- Linkage to Design Validation, Process Validation and Labeling/IFU
- Linkage to Clinical Plans, CER/PER, SSCP/SSP, PMS Plans, PSUR/PMS Report, PMCF Plans
- MDR Article 1 (8) & (9) and Article 117 (12) for Combination Products (Single Integral Product, Principle and Ancillary Action) required to follow GSPR Annex I
- Particular requirements for Digital Health, SiMD and SaMD
- Particular requirements for capital equipment (multi-use devices)
9:30-10:00 Lecture – Medical Device and Pharmaceutical Risk Management Approaches – what can we learn from each other and how to apply to combo products?

10:00-10:30 Coffee Break

10:30-12:00 Exercise – RMF Lifecycle: Design, Clinical and Post-Market Activities
- Begin with the end in mind. Start with a PHA / CHL & link to FMEA
- PHA/CHL – Hazards, Hazardous Situations, Harms, P2 probability of harm, Severity, and Complaint Codes – Linking to Art 88 and trend reporting (use of IMDRF codes)
- FMEA – Failure mode, effects = hazards/hazardous situation linkage from PHA/CHL, P1 probability of failure, linkage to design and process validation, and labeling

12:00-13:00 Lunch Break

13:00-13:45 Didactic / Lecture with Case studies – PMS and Clinical Evaluation Plans
- “Suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis”
13:45-14:30 Lecture – Developing Risk-Acceptability Criteria
- Compliant to MDR, ISO 14971:2019, and consistent with pre-market (DV&V, investigation, literature data) and post-market (investigation, literature, complaints/vigilance)
- Overall methodology and criteria (per ISO 14971:2019)
- Linking DV&V statistics (sampling plan AOQL/RQL; reliability estimates to RAC)
- Linking Investigation & Literature to RAC

14:30-15:00 Coffee Break

15:00-15:45 Lecture – Disclosure of Residual Risk from a Notified Body Perspective
- GSPR 4 … “Manufacturers shall inform users of any residual risks.”
- GSPR 23.4(g) [IFU to include] “… any residual risks, contra-indications and any undesirable side- effects, including information to be conveyed to the patient in this regard;”
- Hence, must EVERY residual risk be disclosed? Do I need to QUANTIFY the harms which can occur (since that's implied by the definition of "risk") or can I simply list them?
- What to do now that ISO 14971:2019 is now harmonized to MDR and only requires “significant risks” to be disclosed?

15:45-16:00 Workshop Conclusions