CMC Regulatory Compliance for Biologics

A CMC approach to IMPD Walkthrough for Biologics

27 – 29 October 2025

1 850 €

TRAINING TIMES

12:00 - 17:00 Vienna

11:00 - 16:00 London

07:00 - 12:00 New York

04:00 - 09:00 Los Angeles

WHY SHOULD YOU ATTEND?

Regulatory Requirements

Receive a comprehensive regulatory update including IMPD and CTD. Understand EU an FDA regulatory expectations. Apply ICH guidelines and identify common pitfalls and prepare strategies for avoiding them.

CMC is Quality

Apply QbD principles and interpret data requirements for DS and DP sections of the CTD. We will walk thorough tech transfer, validation and stability in the context of your CMC submission as well as tools for implementing robust change control and lifecycle management.

Up-to-date

This workshop has a long history, consistently positive feedback and this new edition has been fully revamped thanks to feedback from companies such as Lonza, GSK, Takeda, Regeneron, Gilead, CSL and others.

Highly Interactive Live Format

The workshop is based upon worked examples but also enables participants to discuss their products (without breaching intellectual property restrictions!). We activate participants with case studies, discussions and on-the-spot problem solving.

OUR ONLINE TRAINING EXERIENCE INCLUDE

Live, Interactive Format

Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

Full Access via Client Zone

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Certificate of Completion

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

LEARNING OBJECTIVES

Regulatory Update

Understand the regulatory structure of the IMPD and CTD, and how it applies to biologic product development

Quality

Apply ICH quality guidelines and Develop a clear control strategy using QbD

Process

From cell line development through to drug product and clinical submission. Manage a plan for effective tech transfer, process validation, scale-up and change

Pitfalls and Regulatory Interactions

Identify common regulatory pitfalls and strategies to avoid them

WHO IS THIS TRAINING FOR?

Regulatory Affairs

CMC Professionals

Quality Control/ Assurance Personnel

Manufacturing Engineers and Managers

Research and Development Scientists

Project Managers

KEY TOPICS

IMPD/CTD Walkthrough: Overview of Module 1 – 5

CTD Module 3: DS & DP data requirements

Manufacturing and Process Development

Change Management: Tools for managing post-approval changes

Reference Standards: Sourcing, characterisation, qualification

Analytical Development: Methods, validation, comparability, critical quality attributes (CQAs)

Stability Studies: ICH Q guidance, real-time and accelerated data

Tech Transfer: Planning, documentation, CDMO coordination

TRAINER

Dr. Len Pattenden

Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.

TESTIMONIALS

Len is a very professional trainer and has extensive knowledge on the subject.

Overall a great course and I got what I was looking for.

Diving into the case studies and the ensuing discussion and learnings were great.

PAST PARTICIPANTS