All about ATMP
Development - Quality - CMC - Authorisation - Market Access
- Authority + industry position
- A wide range of topics on two days
- Examples for implementation in practice
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
From
1.990,00 €
plus VAT
Services & Process
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day 1: 09:00 am - 05:00 pm CET - Online training
Day 2: 09:00 am - 05:30 pm CET - Online training
You may dial in 30 minutes before the session starts
Booking details
Online-Seminar
From
1.990,00 €
plus VAT
Services & Process
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day 1: 09:00 am - 05:00 pm CET - Online training
Day 2: 09:00 am - 05:30 pm CET - Online training
You may dial in 30 minutes before the session starts
The online training with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA: first experiences with ATMPs) for advanced therapy medicinal products. Qualifiy now!
Your speakers
Dr. Ralf Sanzenbacher
Paul-Ehrlich-Institut (PEI), Langen, GERMANY
Keine ausführliche englische Beschreibung vorhanden
Your speaker
Dr. Ralf Sanzenbacher
Paul-Ehrlich-Institut (PEI), Langen, GERMANY
Keine ausführliche englische Beschreibung vorhanden
Dr. Thorsten Meyer
Granzer Regulatory Consulting & Services GmbH,
Munich, GERMANY
Senior Consultant
Your speaker
Dr. Thorsten Meyer
Granzer Regulatory Consulting & Services GmbH,
Munich, GERMANY
Senior Consultant
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…
Your speaker
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.
Dr. Michael Jandke
Independent consultant
Since August 2024, Dr Jandke has been serving as an independent consultant.
Prior to that, he worked at Miltenyi from 2019, where he held responsibility for Regulatory Affairs…
Your speaker
Dr. Michael Jandke
Independent consultant
Since August 2024, Dr Jandke has been serving as an independent consultant.
Prior to that, he worked at Miltenyi from 2019, where he held responsibility for Regulatory Affairs across the European Union. Before his tenure at Miltenyi Biomedicine, Michael held various leadership roles within innovative healthcare companies, focusing on areas such as somatic cell-based medicinal products (sCBMP), tissue-engineered products (TEP), and gene therapeutics, as well as in the generic pharmaceutical sector.
Dr Jandke studied Pharmacy at Humboldt University in Berlin and earned a Doctorate in Molecular Medicine from the same institution.
Dr. Sandra Kiehlmeier
WS Value & Dossier GmbH,
Eschborn, GERMANY
Senior Market Access Manager / Medical Writer
Your speaker
Dr. Sandra Kiehlmeier
WS Value & Dossier GmbH,
Eschborn, GERMANY
Senior Market Access Manager / Medical Writer
Dr. Sabrina Schmeckebier
Paul-Ehrlich-Institut, Langen, GERMANY
Your speaker
Dr. Sabrina Schmeckebier
Paul-Ehrlich-Institut, Langen, GERMANY
What to Expect
- From blood, tissues & cells to ATMP
- GMP and Module 3 requirements for ATMPs
- Requirements for clinical and non-clinical development
- Classification of ATMPs
- Hospital exemption vs. central approval process
- Early benefit evaluation, including an update on the EU HTA (focus in general on Germany)
Who Should Attend
This seminar is aimed at specialists and managers in the pharmaceutical and biotechnology industry who work with gene-, cell- and tissue-based products or plan to do so in the future.
The aim is to impart ‘basic knowledge’ for beginners in the field.
Objective of the Event
During this seminar, you will learn to master the challenges from development to approval to market access of an ATMP.
After the seminar, you will know which GMP regulations must be included for ATMPs as part of product development.
You will be familiar with the requirements for clinical and non-clinical development too. In addition, you have been brought up to date with regard to the regulatory requirements for marketing authorisation (national, EU). You know the individual steps in the central approval procedure and the requirements for hospital exemption.
Last but not least, you have acquired the know-how to set the right course for benefit assessment and market access (including an update on the EU HTA, first experiences with ATMPs).
Your Benefit
After participating in this online seminar you will be equipped with a tool box as well as practical tipps and hints to master
- your clinical development including GMP-relevant aspects
- the marketing autorisation process - requirements for the central approval procedure and hospital exemption
- the market access strategy.
Your program
Day 1: 9:00 am - 5:00 pm CET
Day 2: 9:00 am - 5:30 pm CET
Day 1
09:00
09:15
Dr Ralf Sanzenbacher
- Overview on product classes, new developments, procedures, responsible authorities, and contact points
10:30
10:45
Dr Ralf Sanzenbacher
- How to define the quality of an ATMP
- GMP for ATMP
11:30
Dr Thorsten Meyer
- Animal models for efficacy and toxicity testings
- Determination of a secure starting dose and therapeutic dose
12:30
13:15
Dr Thorsten Meyer
14:45
15:00
Dr Ralf Sanzenbacher
- National procedures
- Update on regulatory setting for clinical trials and on hospital exemption
16:00
Dr R. Sanzenbacher, Dr Th. Meyer
- Do's and don't's from stakeholder and authority point of view
16:45
17:00
Opening and introduction
09:15
From blood, tissues & cells to ATMP
From blood, tissues & cells to ATMP
Dr Ralf Sanzenbacher
- Overview on product classes, new developments, procedures, responsible authorities, and contact points
Coffee break
10:45
Product development and quality aspects
Product development and quality aspects
Dr Ralf Sanzenbacher
- How to define the quality of an ATMP
- GMP for ATMP
11:30
Requirements for the non-clinical developement of ATMPs
Requirements for the non-clinical developement of ATMPs
Dr Thorsten Meyer
- Animal models for efficacy and toxicity testings
- Determination of a secure starting dose and therapeutic dose
Lunch break
Continuation: Requirements for the non-clinical development of ATMPs
Coffee break
15:00
German national aspects for development and authorisation
German national aspects for development and authorisation
Dr Ralf Sanzenbacher
- National procedures
- Update on regulatory setting for clinical trials and on hospital exemption
16:00
Interaction between companies and authorities
Interaction between companies and authorities
Dr R. Sanzenbacher, Dr Th. Meyer
- Do's and don't's from stakeholder and authority point of view
Q&As
End of seminar day 1
Day 2
09:00
Jessica Cordes
- Ethical and regulatory aspects
- Clinical trial planning
- Specifics for clinical trial implementation
11:00
11:15
Dr Sabrina Schmeckebier
- Reflection paper on classification
- Scientific recommendations
- Experiences (CAT); product examples
12:00
12:45
Dr Sabrina Schmeckebier
- Role of the CAT
- The centralised authorization procedure of the EMA
- The risk based approach for ATMPs
- Special authorisation procedures
13:45
Dr Michael Jandke
- Critical quality data from pharmacutical development, characterisation, production, control strategy
15:30
15:45
Dr Sandra Kiehlmeier
- AMNOG process
- ATMPs and Orphan drugs
- Application accompanying data collection
- Results and experiences
- EU HTA: first experiences with ATMPs
17:00
17:30
09:00
Clinical aspects to be considered during ATMP development
Clinical aspects to be considered during ATMP development
Jessica Cordes
- Ethical and regulatory aspects
- Clinical trial planning
- Specifics for clinical trial implementation
Coffee break
11:15
Classification of ATMPs
Classification of ATMPs
Dr Sabrina Schmeckebier
- Reflection paper on classification
- Scientific recommendations
- Experiences (CAT); product examples
Lunch break
12:45
Centralised authorisation procedure
Centralised authorisation procedure
Dr Sabrina Schmeckebier
- Role of the CAT
- The centralised authorization procedure of the EMA
- The risk based approach for ATMPs
- Special authorisation procedures
13:45
Essential module 3 data for ATMPs
Essential module 3 data for ATMPs
Dr Michael Jandke
- Critical quality data from pharmacutical development, characterisation, production, control strategy
Coffee break
15:45
Early benefit evaluation for ATMPs
(focus Germany)
Early benefit evaluation for ATMPs (focus Germany)
Dr Sandra Kiehlmeier
- AMNOG process
- ATMPs and Orphan drugs
- Application accompanying data collection
- Results and experiences
- EU HTA: first experiences with ATMPs
Concluding discussion
End of training course
Downloads
Request the documents using our form.
Abbreviations-Drug-Regulatory-Affairs-and-CMC
Zusatzinformationen
Optional online test/learning success control
After taking part in the seminar, you can take our online multiple-choice test.
This can be completed online up to 14 days after the event in order to document the acquired knowledge with a special certificate.
Taking the online test is optional. You will receive a certificate of participation regardless.
Benefits of a FORUM Institut training course
FORUM Institut's all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
- Live and interactive learning on our Learning Space training platform
- A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
- Easy surveys with Slido
- 'Deluxe' chat: group chats, one-to-one chats, one-to-one video chats
- A central repository for documents and media
- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
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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We are happy to advise you personally and individually.
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Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de