Pharmaceutical Development of ATMPs (Advanced Therapy Medicinal Products) Training Course (February 6-9, 2023)

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Oct 18, 2022, 15:30 ET

DUBLIN, Oct. 18, 2022 /PRNewswire/ -- The "Pharmaceutical Development of ATMPs Training Course" conference has been added to ResearchAndMarkets.com's offering.

This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).

Industry experts will cover the regulatory landscape and the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges.

The differences between GMP for ATMPs and conventional therapies will be discussed, as will the requirements for clinical trials and the preparation of the IMPD. Advice on the specific transportation requirements of these products will also be addressed.

This programme will be of benefit to all those involved with or considering developing an ATMP.

Benefits of attending:

Understand the GMP requirements for clinical trials in the US and Europe
Gain a practical insight into other markets
Determine critical quality attributes
Develop a successful QC strategy
Examine the major differences between GMP for ATMPs and conventional therapies
Overcome potential pitfalls when manufacturing cells
Discuss multi-manufacturing sites for autologous products
Consider stability issues
Examine risk analysis for biological materials and understand Annex 16
Gain an introduction to GMO approval requirements

This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.

Who Should Attend:

R&D personnel involved in research on cell or gene-based therapies
Managers involved in the development and manufacture of ATMPs
Quality assurance and quality control personnel responsible for quality aspects of ATMPs
GMP managers responsible for implementing GMP in ATMP manufacture
Regulatory personnel involved in inspections of ATMPs

Key Topics Covered:

Introduction to ATMPs

Definition of ATMPs and associated terms
Classification of ATMPs

The Regulatory Landscape

Examining the European regulatory landscape for ATMPs - detailed analysis of existing regulation 1394/2007
Considering factors lying outside of the regulation's scope, e.g. combination products
Links to related directives, eg Tissues and Cells Directives (2002/98/EC and 2004/23/EC); Medical Device Directive (93/42/EEC) and forthcoming regulation

Strategic Considerations

Opportunities to meet with regulators to maximise approval chances
ATMP-specific options in the EU: certification procedure, risk-benefit approach
Accelerated access opportunities in EU and US
Understanding breakthrough status/PRIME

Insight into Global Regulations and Requirements

Examining key markets including Europe, US and Japan
Evaluate the regulatory differences between regions to help you build a strategic approval route
GMP requirements at Phase I in US and Europe - ramifications for your product

Overcoming Quality Challenges

Overview of frequent quality concerns
Potency assay development
Determining critical quality attributes
Developing a successful QC strategy for short-shelf-life product
QP release: timing and logistical challenges for ATMPs

Understanding Clinical Trials

EU clinical trial requirements
The US IND

Risk-Based Approach for ATMPs

Examining 3.2.A Adventitious Agents
Level of data required EU/US

GMP for ATMPs

What is required: examine the major differences between GMP for ATMPs and conventional therapies
Overcoming potential pitfalls when manufacturing cells
Current GMP interpretations
Multiple manufacturing sites for autologous products
Point-of-care preparation devices

Stability and Logistics

Considering stability issues
Challenges in transporting cell therapies/cryopreservation
Preparation on site

Clinical Trial Considerations

Optimising materials for regulatory compliance - vendor qualification
Risk analysis for biological materials
The comparability concept and its importance in preparing for clinical trials
Introduction to GMO approval requirements

Practical Considerations for the IMPD

Terms and definitions
Guidance on IMPD content for ATMPs
Data requirements for first-in-human vs later clinical trials

Speakers

Andrew Willis
Consultant
Independent

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world's leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis.

He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.

He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.

For more information about this conference visit https://www.researchandmarkets.com/r/35pnoc

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