Dr Rainer Gnibl
GMP Inspector
Referierende
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr Katja Aschermann
Astator
Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult, formerly F.Hoffmann-La Roche
Kati Kebbel
Fraunhofer-Institut für Zelltherapie und Immunologie IZI
Highlights
- Impact of Annex 1 in the aseptic manufacturing of HCGTP
- Case study for a clinical phase I/II CAR T cell product
- Case Studies of ATIMP Batch Releases
- Impact of Annex 1 in the aseptic manufacturing of HCGTP
- Case study for a clinical phase I/II CAR T cell product
- Case Studies of ATIMP Batch Releases
Zielgruppe
This training is aimed at employees from quality assurance, quality control and production who have daily contact with ATMPs and have to work according to the existing GMP requirements. Experienced staff will have the opportunity to extend and deepen their existing knowledge in core aspects of GMP and Annex 1 areas.
Zielsetzung
The new Annex 1 is in effect and must now be implemented. The correct interpretation and implementation in daily business is often difficult and raises many questions. Compliance with the GMP regulations is essential for the continuous, traceable and high-quality manufacture, testing and control of pharmaceutical products.
Advanced Therapy Medicinal Products (ATMPs) are a group of innovative and sophisticated medical treatments that use advanced technologies to modify or use living cells, tissues or genes for therapeutic purposes. These therapies focus on targeting the underlying causes of disease at the cellular and genetic level, with the aim of treating, preventing or diagnosing diseases. ATMPs include gene therapies, cell therapies and tissue engineered products and represent a significant step in medical treatments.
New ATMPs with innovative properties are constantly being developed. It does not matter whether it is a personalized product, production or even transport. The ultimate goal always remains a safe and effective product that provides the patient with healing or relief without harming them. To ensure this, employees must comply with the current regulations. This course offers deeper insights into the regulations and advice on implementing the new and existing requirements of ATMPs.
As part of this GMP course for ATMPs (Advanced Therapy Medicinal Products), you will learn about the existing regulatory requirements for aseptic manufacturing, CCS, data integrity according to the new Annex 1 and much more from various experts from authorities, industry and consulting. In addition to the GMP requirements, you will also learn about the impact and implementation of the new Annex 1.
Advanced Therapy Medicinal Products (ATMPs) are a group of innovative and sophisticated medical treatments that use advanced technologies to modify or use living cells, tissues or genes for therapeutic purposes. These therapies focus on targeting the underlying causes of disease at the cellular and genetic level, with the aim of treating, preventing or diagnosing diseases. ATMPs include gene therapies, cell therapies and tissue engineered products and represent a significant step in medical treatments.
New ATMPs with innovative properties are constantly being developed. It does not matter whether it is a personalized product, production or even transport. The ultimate goal always remains a safe and effective product that provides the patient with healing or relief without harming them. To ensure this, employees must comply with the current regulations. This course offers deeper insights into the regulations and advice on implementing the new and existing requirements of ATMPs.
As part of this GMP course for ATMPs (Advanced Therapy Medicinal Products), you will learn about the existing regulatory requirements for aseptic manufacturing, CCS, data integrity according to the new Annex 1 and much more from various experts from authorities, industry and consulting. In addition to the GMP requirements, you will also learn about the impact and implementation of the new Annex 1.
Programm
EU-GMP Guideline Part IV: Overview
- Positioning within EudraLex Vol. 4
- Definition of ATMPs
- Document structure & technical content
- Key messages
Quality Risk Management for ATMPs
- What does QRM mean?
- ICH Q9 Quality Risk Management (Overview)
- Bounderies & limitations
- Examples from Guideline
Specific Aspects for viral and non-viral Vectors
- Points to consider when handling GMOs under GMP
- GMPs and Pharm. Eur. monograph on gene therapy medicinal products
- Viral clearance of viral products
Aseptic Manufacturing of Cell-based ATMPs (HCGTP)
- Challenges
- Impact of new Annex 1
- Cross Contamination Control Strategy
Environmental Monitoring
- Segregation between Classification, Qualification & Monitoring
- Clean room lifecycle
- Monitoring elements
- Personell- & clean room monitoring
Data Integrity of Automated, Decentralised Cell Therapy Production
DI concept in research-oriented smaller companies
Computer-assisted manufacturing of therapeutics
DI issues in testing, release and logistics
Impact of the revised EU GMP Chapter 4, Annex 11 and new Annex 22
DI questions in the context of inspections
Contamination Control Strategy
Definition
Creation of a CCS
Selected items
Qualification and Validation – a Versatile and Efficient Quality Tool in the ATMP Manufacturing
DI concept in research-oriented smaller companies
Computer-assisted manufacturing of therapeutics
DI issues in testing, release and logistics
Impact of the revised EU GMP Chapter 4, Annex 11 and new Annex 22
DI questions in the context of inspections
Contamination Control Strategy
Definition
Creation of a CCS
Selected items
Qualification and Validation – a Versatile and Efficient Quality Tool in the ATMP Manufacturing
- Clarification of types of qualification and validation applied in ATMP manufacturing
- supplier qualification
- device qualification
- software validation - (Aseptic) process qualification / Validation
- method Validation
- operator qualification - Regulatory basis
- How are these types used in the ATMP manufacturing - described in a case study for a clinical phase I/II ATMP
ATMPs a Challenge for Quality Control
- From product to control strategy via CQAs
- Measurement of quality attributes
- Specifications
- Stability
- Validation
Regulatory Landscape - Opportunities and Challenges
- Overview for ATMPs
- Specific requirements for ATMPs - opportunities and challenges
- Examples on points to consider in CMC
If the Guidelines Vecome a challenge
- Media Growth Promotion Test according to EP 2.6.1 vs. 2.6.27 and impact to sterility method validation
- APS challenges
- Change of standard APS strategy - a future vision?
From starting / raw material to final ATIMP – responsibilities and challenges of a QP
- Regulatory landscape batch release process; 2-step-procedure for certification of ATIMPs and sponsor release
- Case Study 1: product certification of an early clinical stage ATIMP - roles of the QP in an academic project- setting
- Case Study 2: product certification of an early clinical stage IMP with different manufacturing sites – roles of the QP(s) and division of responsibilities
- Case Study 3: product certification - roles of the QP(s) in a Pharma project- setting
Weitere Informationen
Venue
NH Collection Heidelberg
Bergheimer Straße 91
69115 Heidelberg, Germany
Phone +49 6221 1327 0
nhcollectionheidelberg@nh-hotels.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Get-Together
On the evening of the first course day, you are cordially invited to a Get-Together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Mr Clemens Mundo, +49 6221 84 44-42, mundo@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
NH Collection Heidelberg
Bergheimer Straße 91
69115 Heidelberg, Germany
Phone +49 6221 1327 0
nhcollectionheidelberg@nh-hotels.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Get-Together
On the evening of the first course day, you are cordially invited to a Get-Together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Mr Clemens Mundo, +49 6221 84 44-42, mundo@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 19 May 2027, 09:00-16:30 h
(Registration and Coffee 08:30-09:00 h)
Thu, 20 May 2027, 09:00-15:30 h
All times mentioned are CEST
(Registration and Coffee 08:30-09:00 h)
Thu, 20 May 2027, 09:00-15:30 h
All times mentioned are CEST
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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