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: 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.
