Training course on Advanced Therapy
Medicinal Products (ATMPs)

A course to have a good command of
ATMPs and its regulation

I want to know more

    Pharmaceutical regulatory landscape is always changing, evolving, and become more complex every year. 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 and guideline that support the development of Advanced Therapy Medicinal Products (ATMPs) and the specification to consider when building the common technical document and marketing authorisation procedures of ATMPs.

    This course will go through all the procedures that Regulatory Agencies make available to the manufacturers to help and support the development of their products, with special attention to these critical points that can be more problematic when brining and advanced therapy medicinal product to the patients.

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    Main aims of ATMPs Course

    When you finish this course you will accomplish:

    Objective 1.

    Understanding the European Regulatory Framework for an ATMP.

    Objective 2.

    Understanding the possible interactions with Regulatory Agencies, such as Classification of ATMPs and Scientific Advice procedures.

    Objective 3.

    Addressing drossier’s specifications for ATMPs on the different Modules and most common issues.

    Objective 4.

    Addressing Quality/CMC challenges in the development of an ATMP.

    Who Should Attend?

    This course will provide relevant advice to professionals who want to begin or progress in the field of Regulatory Affairs, or for those working in Scientific areas related to Advanced Therapy Medicinal Products that want to know more or get involved in the development process of these products. Such as:

    • – ATMP Manufacturers
    • – CMC Development
    • – Process Development
    • – Clinical Research specialist
    • – QC and Stability
    • – Laboratory Managers
    • – Regulatory Affairs Department

    Course information

    Agenda

    – EU ATMPs legislation.

    – EU Marketing Authorization procedure.

    Break – 10 mins.

    – Scientific Advice

    – ATMP classification

    – PRIME, etc.

    – Innovation Task Force briefing meetings.

     Break – 10 mins.

    – GCP for ATMPs.

    – Guideline on Safety and Efficacy follow-up and Risk Management for ATMPs.

    Lunch time – 60 mins.

    – Starting materials

    – Characterisation, etc.

    – Viral safety.

    – Others

    Break – 10 mins.

    – What is comparability?

    – How to apply the principles of comparability?

    – Case studies.

    Break – 10 mins.

    – What is potency?

    – Why is potency so important?

    – What are the regulatory expectations for potency assays?

    – Case studies.

    Break – 10 mins.

    Trainers

    Maria Reviriego:

    Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers where it was nominated as EMA expert.

    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).

    In 2019, she established herself as an independent consultant and collaborated with Biopharmaceutical Companies and Public institutions in the field of ATMPs.

    In July 2020, she co-founded Alladvice Regulatory Consultants, a Regulatory Consultancy created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs) for human use, across all phases of the development, from non-clinical to post-marketing, to comply with regulatory requirements.

    Lecturer in Pharmaceutical Industry Masters and Congresses.

    Conchi Torrejón:

    More than 11 years’ professional experience across Europe mainly in Regulatory Affairs within the pharmaceutical industry including the multinational Takeda in London (UK).

    She worked in Regulatory Affairs in TiGenix (currently Takeda) where among other projects with ATMPs (e.g., Chondrocelect), she was involved in the successfully approval of the European Marketing Authorization of Alofisel (first authorization for an allogeneic cell therapy product in Europe).

    She has collaborated with public institutions in the field of ATMPs and also with the Pharmacovigilance department at the Spanish Agency of Medicines and Medical Devices (AEMPS).

    In July 2020, she co-founded Alladvice Regulatory Consultants, a Regulatory Consultancy created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs) for human use, across all phases of the development, from non-clinical to post-marketing, to comply with regulatory requirements.

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    Download here the course flyer if you want to know more

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