Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing

Join our experts, and by attending this forum, you will:

• Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing
• Understand the practice surrounding post-approval method changes and its impact on compliance
• Identify when pharmacopoeial methods are necessary and when alternative validated methods may be used
• Gain practical insights into testing comparability between methods and replacing existing methods or instrumentation

Event Overview

Part 1: Overview of Method Life Cycle Management and post-approval changes (17 June, 2025)

To ensure the effectiveness of analytical methods, staying updated on Method Life Cycle Management and Post-Approval Changes is essential. This includes compliance with guidelines such as ICH Q14 for method lifecycle management, the USP <1220> guideline for analytical procedures, and the Eur.Ph. General Chapter 5.27 on the comparability of alternative analytical procedures.

Part 2: Practical approaches to implementing new or renewed analytical procedures (24 June, 2025)  

We’ll focus on practical strategies for integrating new or updated analytical procedures into existing processes. This includes managing the lifecycle of methods in pharmaceutical analysis, transitioning between different analytical methodologies, and two case studies: one on replacing approved analytical methods post-market release and another on using a universal study design for updating instruments in pharmaceutical release analytics.

What you need to know:

Part 1: 17 June, 2025

Part 2: 24 June, 2025

Each day has a dual-time broadcast, with starting times as follows:

• Broadcast #1: 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
• Broadcast #2: 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)

Duration: Approximately 60 – 90 minutes, incl. Q&A.

• Registrants attending this online event’s live broadcast sessions will receive a ‘Certificate of Attendance’.
• Join the BioQC user community for ongoing discussions after the event.

Who should attend?

Anyone interested in the regulation and practice of replacing or updating analytical procedures or instrumentation during drug development or manufacturing. This event provides an overview of current practice and the regulatory landscape on method life cycle management and post-approval changes, as well as Eur.Ph. 5.27 on method comparability.  

• Industry experts involved in analytical procedure development and validation.
• Industry experts involved in compliance and analytical method lifecycle management.
• Quality control/quality assurance personnel.
• Regulatory affairs professionals.
• Academics interested in learning about method development and the pharmaceutical and biopharmaceutical industry regulatory requirements.

Presenters / Panellists

To be confirmed.

Moderators

Prof. Dr. Cari Sänger-van de Griend

Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.

Dr. Ewoud van Tricht

Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.

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