Pharmaceutical Development of ATMPs Seminar: Overview of the Regulatory, Quality and GMP Requirements - London, United Kingdom - October 7-8, 2019

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Jun 03, 2019, 05:00 ET

DUBLIN, June 3, 2019 /PRNewswire/ -- The "Pharmaceutical Development of ATMPs" conference has been added to ResearchAndMarkets.com's offering.

This course will provide a comprehensive to consider when developing ATMPs.

The programme will cover the regulatory landscape, the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. Comparison of the differences between GMP for Advance Medicinal Therapeutic Product (ATMPs) and conventional therapeutics will be discussed. Consideration of what is required for clinical trials and the preparation of the IMPD will also be addressed. Furthermore advice on the specific transportation requirements of these products will be included.

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

Benefits of attending:

Understand the GMP requirements at Phase 1 in 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
Gain an introduction to GMO approval requirements

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

Agenda:

Day one

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 Devices Directive (93/42/EEC) and forthcoming regulation

Understanding clinical trials

EU clinical trial requirements
The US IND

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

Risk-based approach for ATMPs

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

Programme Day Two

GMP for ATMPs

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

Delivery and shipping

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

Preparation for clinical trial

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 Investigational Medicinal Product Dossier (IMPD)

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

For more information about this conference visit https://www.researchandmarkets.com/r/2jx7nt

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