Thijs Kroon
M2K2 radiopharma consultancy
Referierende
Dr Franz Schönfeld
GMP Inspector
Dr Dirk Freitag-Stechl
CUP Laboratorien
Marlous van der Hooft
Qualificiency Consulting
- Annex 1 in practice for radiopharmaceuticals including QRM/CCS implementation and the interface with Annexes 3 and 13
- Inspector’s view on audits: Recurring findings on hot cells, monitoring/validation, process validation and data Integrity
- From early-phase IMP to scale up
- Inspector’s view on audits: Recurring findings on hot cells, monitoring/validation, process validation and data Integrity
- From early-phase IMP to scale up
Zielgruppe
This course is aimed at the personnel of hospitals, pharmaceutical companies, their suppliers and authorities who are involved in
- Quality control
- Quality assurance
- Inspection and audits
- Qualification and validation
- Radiopharmaceutical preparation and/or manufacturing.
Zielsetzung
The manufacturing of radiopharmaceutical products confronts the producing establishment with a range of challenges. On the one hand, there are contradictory requirements arising from pharmaceutical quality and safety guidelines and the standards for staff safety and radiation protection. On the other hand, there are issues related to small batch sizes and a short shelf life. The short shelf life necessitates rapid transportation and administration to the patient. These circumstances mean that classical requirements such as sterility testing before release and administration cannot be fulfilled.
During this course, you will gain a practice-oriented overview of current GMP requirements and regulatory expectations for radiopharmaceuticals. Representatives of regulatory authorities will present recent developments in the EU regulatory framework (including Directive 2001/83/EC and Regulation (EU) No 536/2014), the EU GMP Guidelines and relevant guidance documents, and share their inspection experience from radiopharmaceutical manufacturing sites. A key focus is the impact of Annex 1 on radiopharmaceuticals, including sterility concepts, risk-based implementation (QRM/CCS) and the interface with Annex 3 and Annex 13. In addition, speakers from industry and laboratories will address practical implementation topics such as facility and room design and qualification, analytical method validation (including specific aspects related to Ph. Eur.), rapid microbiological methods, and monitoring and trending. Further sessions cover audit findings from an inspector’s perspective (including hot cells and data integrity), early-phase IMP manufacturing, scale-up challenges (e.g., isotope availability and global supply) and future expectations for radiopharmaceuticals.
During this course, you will gain a practice-oriented overview of current GMP requirements and regulatory expectations for radiopharmaceuticals. Representatives of regulatory authorities will present recent developments in the EU regulatory framework (including Directive 2001/83/EC and Regulation (EU) No 536/2014), the EU GMP Guidelines and relevant guidance documents, and share their inspection experience from radiopharmaceutical manufacturing sites. A key focus is the impact of Annex 1 on radiopharmaceuticals, including sterility concepts, risk-based implementation (QRM/CCS) and the interface with Annex 3 and Annex 13. In addition, speakers from industry and laboratories will address practical implementation topics such as facility and room design and qualification, analytical method validation (including specific aspects related to Ph. Eur.), rapid microbiological methods, and monitoring and trending. Further sessions cover audit findings from an inspector’s perspective (including hot cells and data integrity), early-phase IMP manufacturing, scale-up challenges (e.g., isotope availability and global supply) and future expectations for radiopharmaceuticals.
Programm
Regulatory Requirements for Radiopharmaceuticals
- Directive 2001/83/EC
- Regulation EU No 536/2014
- EU GMP Guidelines and their annexes 1, 3 and 13
- Guidance documents
Overview of Radiopharmaceuticals in Ph. Eur.
- General monographs and chapters in relation to radiopharmaceuticals
- Chemical precursors and radionuclides for radiolabelling
- New developments on therapeutic and PET radiopharmaceuticals
Annex 1 – Impact on Radiopharmaceuticals
- “Sterile” – How, what and why?
- Risk management and CCS approaches for implementation
- Annex 1 Vs. Annex 3
Rooms and Personnel – GMP Requirements for Product Safety
- Design and qualification of facilities
- Containment vs. contamination control
- Training, qualification and monitoring program
QRM Principles – the Modern Way for QA
- Pharmaceutical Quality System, QRM, and risk assessment(s)
- Quality Risk Management (QRM) in manufacturing of sterile medicinal products
- Major changes of Annex 1 (draft) regarding QRM principles
Rooms and Personnel – GMP Requirements for Product Safety
- Design and qualification of facilities
- Containment vs. contamination control
- Training, qualification and monitoring program
Radiation Protection in Pharmaceutical Environment, Safety Challenges and Solutions
- Legal requirements
- Radio protection vs. pharmaceutical requirements
- Process areas in pharmaceutical environment
- Manufacturing risks and challenges
Cleaning and Disinfection Requirements
- General GMP requirements on cleaning and disinfection
- Traditional disinfectants and new methods
- Validation of disinfection procedures
Equipment Qualification & Process Validation in Radiopharmaceutical Production
- Phases of Equipment Qualification
- Principles of Process Validation
- Case studies and Industry Best Practices
Validation of Analytical Methods
- Regulatory Background
- Guidelines and definitions
- The “UNTIE®” process
- Specific application to Ph. Eur. methods
- Additional aspects for radiopharmaceuticals
Evaluation of Rapid Microbiological Methods
- Benefits
- Overview of Methods
- Growth dependent
- Growth Independent - Validation and implementation
- Future challenges
Types and Implementation of Chemical and Microbiological Analyses
- Analysis of precursors, radionuclides and excipients
- Tests of the finished products: Purity, sterility and extractables & leachables
Monitoring Requirements
- Regulatory requirements on Monitoring
- Qualification and routine Monitoring
- Alert and action levels
- Trending of data
Supplier Qualification
- Legal requirements
- Outsourcing - What are suppliers?
- Risk based Approach
- Specific challenges
How to Handle Audits- View of an Inspector
- Hot cell issues
- Monitoring and validation
- Process validation
- Data integrity
- Miscellaneous audit findings over the years
IMP - Early Phase Manufacturing
- Quality expectations during clinical trial phase
- Level of validation
- Differentiation diagnostic and therapeutic radiopharmaceuticals
- From academia to commercial supply
Scale up – Planning, Preparing & Executing
- Potential scale up issues for radiopharmaceuticals
- Global supply
- Isotope availability
- Submission readiness
Future Expectations of Radiopharmaceuticals
- Current status/history
- New diagnostic and therapeutic radiopharmaceuticals
- Future developments in regulations and use of radiopharmaceuticals
Weitere Informationen
Venue
Austria Trend
Hotel Savoyen
Rennweg 16
1030 Vienna, Austria
Phone +43 1 20633
savoyen@austria-trend.at
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.
Get-Together
On the evening of the first course day, you are cordially invited to a Get-Together including dinner. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT)
ECA Members € 2,290
APIC Members € 2,390
Non-ECA Members € 2,490
EU GMP Inspectorates € 1,245
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.
Contacts
Questions regarding content:
Mr Clemens Mundo, +49 6221 84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel, +49 6221 84 44 43, thiel@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 07 September 2027 08:30-16:00 h
(Registration/Coffee 08:00-08:30 h)
Wed, 08 September 2027, 08:30-16:00 h
Thu, 09 September 2027, 08:30-12:30 h
All times mentioned are CEST
(Registration/Coffee 08:00-08:30 h)
Wed, 08 September 2027, 08:30-16:00 h
Thu, 09 September 2027, 08:30-12:30 h
All times mentioned are CEST
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
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 Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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