Yahoo Finance 2 Day Pharmaceutical Development of ATMPs (Advance Medicinal Therapeutic Products) Training Course (October 6-7, 2022)
Dublin, Sept. 28, 2022 (GLOBE NEWSWIRE) -- 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 seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.
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
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
For more information about this conference visit https://www.researchandmarkets.com/r/xt1n02
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
