Target Group
- Research & Development
- Quality Assurance
- Regulatory Affairs
- Production
- Engineering
- Quality Control
Objectives
Background
Programme
- Physiology (if you can use such a word)
- Replication cycles
- Vectors
- Resistance properties
- Viral safety approach: Regulations and principles
- Virus testing concept
- Methods for detection of exogenous & endogenous virus
- Virus contamination of starting material for biologicals
- Dedicated virus reduction steps vs. manufacturing steps for protein purification and concentration
- Down scaling of manufacturing steps for virus clearance studies
- Virus clearance studies
- Virus spike preparation
- Controls as cytotoxicity / interference / balance / inctivation kinetic
- Virus detection methods – infectivity vs. NAT
- Robustness of virus reduction methods / DoE studies
- ICH Guidelines (ICH Q5A)
- European Guidelines (EMEA)
- European Pharmacopoeia
- Risk assessment
- Clinical trials in Europe
- Adventitious agents contamination control strategies
- Facility segregation & risk analysis
- Methods of risk assessment and minimization
- Case studies
- Strategies for ensuring product quality and safety
- What to consider and how to perform risk assessments regarding pathogen safety
- Deviations and change management
- Case studies
- Technology & applications
- Regulations, e.g., in ICH Q5A & Ph. Eur.
- Applications
- Oncolytic viruses: Mode of action & adventitious virus safety approach
- AAV – efficient gene therapy vector
- Production of AAV for gene therapy
- Quality Control of AAV
- Clinical applications of AAV
- Regulatory background/certification
- Gene therapy medicinal products
- Cell based medicinal products
- Nature and transmission of TSE agent
- TSE agent detection methods
- Prion reduction methods
- EU legislation / EMA note for guidance / reflection paper
- EDQM TSE Certification
Further Information
Venue
Qube Hotel Bahnstadt
Grüne Meile 21
69115 Heidelberg, Germany
Phone: +49 (0) 62 21/18 79 90
bahnstadt@qube-heidelberg.de
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.
Social Event
On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
Academic Scientists/Students € 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.
Contacts
Questions regarding content:
Mr Clemens Mundo, +49 6221 84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49 (0) 62 21/84 44 25, bauer@concept-heidelberg.de.
Date & Time
(Registration/coffee 08.00 - 08.30 h)
Wednesday, 04 March 2026, 08.30 - 16.30 h
Costs
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
