2025-04-30 2025-04-30 , online online, 1,290 € zzgl. MwSt. Jessica Cordes https://www.forum-institut.de/seminar/25082550-gcp-for-atmp/referenten/25/25_08/25082550-course-gcp-for-atmp_cordes-jessica.jpg GCP for ATMP

Are you involved in the planning and conduction of clinical trials with ATMP? Do you require current knowledge on the latest GCP guideline (ICH E6 (R3)) AND ATMP-specific considerations? Then join this seminar to stay informed (including training certificate)!

Topics
  • The regulatory landscape for ATMP - where to find information?
  • ICH E6 (R3) obligations for sponsors and investigators, and ATMP-specific considerations
  • Clinical trial design and trial documentation
  • Risk management: common pitfalls of ATMP
  • Patient safety and safety reporting, ATMP-specific reporting requirements
  • Handling of ATMP as a clinical trial drug and maintaining traceability


Who should attend
This online seminar will be of benefit to professionals in Clinical, Medical, and Regulatory Affairs who are involved in Advanced Therapy Medicinal Products (ATMP) clinical development and seek to:

  • master the specific requirements for planning and conducting ATMP clinical trials, and
  • understand where the distinctive features of this product class come into play.

This course will be conducted in English.
Aims and objectives
Clinical trials involving Advanced Therapy Medicinal Products (ATMPs) present unique complexities, demanding adherence to Good Clinical Practice (GCP) guidelines alongside specialised knowledge of these innovative substances.

This comprehensive course bridges the gap between regulatory mandates and practical implementation, equipping you with the tools to succeed in ATMP study planning and conducting.

Upon completion of the seminar, you will be up-to-date on the latest developments according to ICH E6 (R3) and you will understand the key aspects that demand special attention when working with ATMP. You also receive a certificate after the seminar, which serves as proof of your qualification.
Your benefit

Compact one-day course with current knowledge on the latest GCP guideline (ICH E6 (R3)) paired with ATMP-specific aspects.

Course GCP for ATMP

GCP for ATMP

Bridging Regulatory Requirements and Practical Handling

Benefits
  • Specialised ATMP insights combined with core GCP proficiency
  • Including lessons learnt for audits and inspections
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 25082550

Jetzt buchen

JETZT Buchen
Referent

Jessica Cordes

Clinical Excellence GmbH, Munich, GERMANY

Senior Consultant and Trainer Jessica Cordes started her Clinical Operations career in 2009, working at various companies including big pharma and several small-midsized biotech companies. She gained extensive experience on different levels from country study management, global study management and since 2018 global leadership. During her time at Medigene and Immatics, she had structured the Clinical Operations department, built cohesive global teams and implemented GCP and ATMP compliant processes. Since 2013 she is working for oncology clinical trials (including hemato-oncology as well as solid tumors), since 2018 also including clinical trials with Advanced Therapy Medicinal Products (ATMPs). Since the end of 2023 she has been self-employed and advises pharmaceutical companies on all matters relating to clinical operations.
More information please click here.

Alles auf einen Blick

Termin

05/08/2025

05/08/2025

Zeitraum

09:00-17:00 CE(S)T
You may dial in 30 min before the session

09:00-17:00 CE(S)T
You may dial in 30 min before the session
Veranstaltungsort

online

online

Downloads
Abbreviation list Clinical Research PROSPEKT
Abbreviation list Clinical Research PROSPEKT
Gebühr

Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Regine Görner
Dr. Verena Klüver

r.goerner@forum-institut.de
v.kluever@forum-institut.de

Details

Are you involved in the planning and conduction of clinical trials with ATMP? Do you require current knowledge on the latest GCP guideline (ICH E6 (R3)) AND ATMP-specific considerations? Then join this seminar to stay informed (including training certificate)!

Topics

  • The regulatory landscape for ATMP - where to find information?
  • ICH E6 (R3) obligations for sponsors and investigators, and ATMP-specific considerations
  • Clinical trial design and trial documentation
  • Risk management: common pitfalls of ATMP
  • Patient safety and safety reporting, ATMP-specific reporting requirements
  • Handling of ATMP as a clinical trial drug and maintaining traceability


Who should attend
This online seminar will be of benefit to professionals in Clinical, Medical, and Regulatory Affairs who are involved in Advanced Therapy Medicinal Products (ATMP) clinical development and seek to:

  • master the specific requirements for planning and conducting ATMP clinical trials, and
  • understand where the distinctive features of this product class come into play.

This course will be conducted in English.

Aims and objectives

Clinical trials involving Advanced Therapy Medicinal Products (ATMPs) present unique complexities, demanding adherence to Good Clinical Practice (GCP) guidelines alongside specialised knowledge of these innovative substances.

This comprehensive course bridges the gap between regulatory mandates and practical implementation, equipping you with the tools to succeed in ATMP study planning and conducting.

Upon completion of the seminar, you will be up-to-date on the latest developments according to ICH E6 (R3) and you will understand the key aspects that demand special attention when working with ATMP. You also receive a certificate after the seminar, which serves as proof of your qualification.

Your benefit

Compact one-day course with current knowledge on the latest GCP guideline (ICH E6 (R3)) paired with ATMP-specific aspects.

Detailed programme

09:00-17:00 CE(S)T
You may dial in 30 min before the session

Jessica Cordes

Regulatory landscape for ATMP
  • The unique category of Advanced Therapy Medicinal Products (ATMP)
  • ATMP specific guidelines and documents - where to find information?
  • GCP specific to ATMP (C (2019) 7140 final)
  • Guideline on the risk-based approach (ATMP)
  • Safety, efficacy follow-up and risk management of ATMP
  • NEW: Guideline on quality, non-clinical and clinical requirements for investigational ATMP in clinical trials

Responsibilities, qualification, training
  • Sponsor obligations according to ICH E6 (R3) and ATMP-specific aspects
  • Principal investigator's obligations and site personnelGeneral GCP-requirements
    • Focus ATMP: Knowledge about/experience with ATMP products?
    • Unit qualification, trainings and certificates (GMO, JACIE)
  • GCP accordance, protocol deviations

Jessica Cordes

Clinical trial design
  • Population: risks/benefits for participants (genetical, biological, ethnic factors/health status)
  • Endpoints and study objectives (biomarkers, long-term effects, immune response)
  • Quality by design and fitness for purpose
    • The meaning for study protocol and operational criteria
    • Critical to quality factors
  • Essentials regarding ATMP in informed consent form and process

Jessica Cordes

Risk management
  • The risk management concept
  • Common pitfalls of ATMP
    • Regulatory challenges
    • Manufacturing risk
    • Consistency and quality control
    • Safety and efficacy
    • Microbial contamination
  • Clinical trial monitoring as important RM tool
    • Monitoring concepts in ATMP trials and risk-based approachesPractical issues: adjustments in forms, reports etc.

Jessica Cordes

Patient safety and safety reporting
  • Definitions: AE, ADR, SAE, UADR
  • ATMP-specific reporting requirements (long-term follow-up, immunological reactions, traceability)
  • Reporting forms/data capture system: adaptions for combined ATMP
  • Reporting timelines

Jessica Cordes

Clinical trial documentation
  • The importance of good documentation (ALCOA++)
  • Essential Records und the Trial Master File (TMF)
    • DIA Reference Model
    • Risk-based quality assessment: which documents to focus to achieve a high-quality TMF?
  • Archiving requirements

Jessica Cordes

Handling of ATMP as clinical trial drug
  • Drug, comparator, placebo - not quite easy with ATMP
  • Dosing: aspects to consider
  • ATMP quality (handling, storage and transport conditions)
  • ATMP traceability (GMP for ATMP) and retention samples

Jessica Cordes

Wrap-up: Lessons learnt for audits and inspections

Further information

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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