Marine Lepoutre
E&L Global SME
Marine Lepoutre, Global Subject Matter Expert for GSK Vaccines
Marine LEPOUTRE currently holds the position of Global Subject Matter Expert in Extractable & Leachable at GSK Vaccines and is responsible for aligning all GSK Vaccines sites with current regulatory requirements. Before this position, in his role of process expert for Belgium site, she leads process validation as homogeneity, holding time, lifetime and lyophilisation. Marine is a Chemical Process Engineer with a master’s degree in Chemistry from CPE Lyon in France.
DAY 2: February 28th, 2025
SESSION: Managing New Requirements Alongside USP 665 Compliance
The goal will be to present how to effectively handle additional new requirements in parallel with USP 665 (including USP 661.1, 661.2, 662, 382, 383, and EP 4.2.35) and transition from strategy to a fully implemented and operational USP 665 compliance program.
Strategy Program: From Presentation to Implementation:
◆ Key Learnings: Insights gained from the transition of the strategy program from its presentation at the previous conference to its current implementation and usage.
◆ Key Difficulties Faced During Implementation: Challenges encountered while putting the strategy program into practice.
◆ Management of Labs and Testing: Approaches and methods used to manage laboratory operations and testing procedures.
◆ Workload Management: Strategies employed to handle and distribute workload effectively.
◆ Digitalization as a Key Element: The role of digitalization in enhancing the efficiency and effectiveness of the strategy program.
◆ Managing Additional Requirements in Terms of E&L: How to address and incorporate additional requirements related to Extractables and Leachables (E&L).
◆ Additional Testing for Cured Silicone Elastomers (USP 383): Specific testing protocols for cured silicone elastomers as per USP 383 standards.
◆ Plastic Packaging Systems vs. Physicochemical Testing (USP 661.2): Comparison between plastic packaging systems and physicochemical testing requirements outlined in USP 661.2.
◆ Glass Container Requirements in Terms of Extractables (Future USP 660): Anticipated requirements for glass containers concerning extractables, as per the upcoming USP 660 standards.
◆ Metallic Packaging Systems (USP 662): Standards and testing requirements for metallic packaging systems according to USP 662.
DAY 2: March 8th, 2024
SESSION: Cumulative effect vs lego mode: how to simplify extractable approach
The goal will be to present how to manage the cumulative effect and to explain which simplifications can be implemented for extractable studies and patient exposure scenario:
◆ Why extractable studies are not always representatives?
◆ How to deal with cumulative effect described in regulations?
◆ The concept of Lego approach to simplify cumulative evaluation?
◆ How to use of digital tool to support approach and simplify patient exposure scenario and toxicological evaluation?
DAY 2: March 10th, 2023
SESSION: How to implement USP 665 requirements before 2026
◆ Management of existing items, lifecycle and retrospective approach.
◆ Management of new items created between 2021 and 2026
◆ Ensure full compliance for items after 2026.
◆ Quid of Chinese pharmacopea?
DAY 2: March 31st, 2022
SESSION: How to construct a quality risk assessment to define E&L requirements for sus in parenteral processes?
◆ Advantages / Risks of SUS.
◆ Balance between Fixed Equiment & SUS and regulatory evolution.
◆ Leachable Risk assessment: steps, methodology and associated testing requirements.
◆ Open discussion and conclusion on E&L requirements.
