TRAINING COURSE ON ADVANCED
THERAPY MEDICINAL PRODUCTS (ATMPs)
A course to have a good command of ATMPs and its regulation.
Pharmaceutical regulatory landscape is always changing and evolving. Understanding the regulatory environment is vital for the pharmaceutical development of a product, especially for advanced and innovative medicinal products that may lack new guidelines and expertise from the Regulatory Authorities.
This course will review the role and evolution of the most relevant Regulatory Agencies, the different procedures that supports the development of Advanced Therapy Medicinal Products (ATMPs) and the specification to consider when building the common technical document and marketing authorisation.
Main Objectives of ATMPs COURSE
Comprehending the European Regulatory Framework for an ATMP.
Understanding the possible interactions with Regulatory Agencies, such as Classification of ATMPs, Orphan Designation or Scientific Advice procedures.
Remiting dossier’s specifications for ATMPs on the different Modules for Clinical Trial Applications and Investigational Medicinal Product Dossiers and most common issues.
Addressing Quality/CMC challenges in the development of ATMPs.
Who Should attend this course?
This ATMP course is designed and targets a diverse range of professionals with specific expertise in the field that want to know more about. The development process of these products. The course is specifically focus on:
- ATMP Manufacturers and Commercialization
- CMC Development
- Process Development
- Clinical Research Specialist
- QC and Stability
- Laboratory Managers
- Regulatory Affairs Department
- Scientists and Researchers
- Healthcare Professionals
- Industry Professionals and Entrepreneurs
Overview of the European Legislation for Advanced Therapies, displaying the different Regulations and Directives that define and classify advanced therapies, the marketing authorisation procedure of ATMPs at EMA, compassionate use and hospital exemption.
A scientific look on the different types of advanced therapies: gene therapies, cell therapies tissue engineered products and combined products. Examples of previous advanced therapies approved by EMA and cases studies of classifications of products.
A walkthrough of different interactions and procedures available at the EMA to support the development of advanced therapies such as ATMPs Classification Procedure, PRIME Scheme, Orphan Designation, Innovation Task Force and Scientific Advice, their requirements, how to apply and how developers would benefit.
An explanation on the Clinical Trial Application (CTA) procedure with the types of documents and information to be included, the implications of the new Clinical Trials Information System (CTIS) and the content of the CTA, the Investigational Medicinal Product Dossier (IMPD) following CTD structure and amendments on these documents.
Reviewing the Good Manufacturing Practices requirements for ATMPs as displayed in the GMP Guidelines: EudraLex Volume 4: Good Manufacturing Practice specific to Advanced Therapy Medicinal Product.
Discussing the most common quality challenges faced in the development of ATMPs: Starting Materials, Characterisation, Comparability, Potency or Viral Safety, among others. Cases studies on these issues, how to evade or overcome them.
Date: 14th November 2023
Cost: 450 €
Morning 9:00 am to 13:00 pm, Afternoon 14:00 pm to 16:00 pm
Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.
More than 20 years’ professional experience across Europe mainly in Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different biopharmaceutical companies and business models.
She worked as Regulatory Affairs Head in TiGenix (currently Takeda) where among other projects with ATMP, she was actively involved in the successfully approval of the European Marketing Authorization of Alofisel (first authorization for an allogeneic cell therapy product in Europe).
Since April 2019 she established herself as an independent consultant and has collaborated with Biopharmaceutical Companies and Public institutions in the field of ATMPs.
Lecturer in Pharmaceutical Industry Masters.
JOSÉ MANUEL DÍAZ PIQUERAS
Graduated in Biology, with a Master in Virology and a Master in Bioscience Enterprises.
With professional experience as a researcher in a Microbiology Laboratory and as a Pharmaceutical Regulatory Consultant from Alladvice Regulatory Consultants and Revio Pharmaceutical Consultants.
He has worked in different national and international regulatory processes such as Scientific Advice, PRIME, Innovation Task Force Meeting, National Authorizations, Orphan Designation. etc.
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