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

2022-10-18

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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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