Target Group
Objectives
You will learn what you need to know from a GMP perspective about
- the basic requirements for drug approval in Europe, the US and Japan
- the structure of the marketing authorisation dossier according to the CTD
- the input from the GMP regulated Departments
- drug approval procedures in the EU and US
- documents to be provided and timelines to be observed
- how to handle changes and variations in the EU, the US and Japan
For the maintenance of a marketing authorisation it is very important to know how to handle all the changes and variations occurring during the life cycle of a medicinal product. The rules for handling variations in Europe are laid down in the variations regulation (EC) No. 1234/2008 – being applicable as well for national marketing authorisations from August 3rd 2013 – and supporting guidelines. For handling changes in the US rules are provided in different guidances for industry and for approval of changes in Japan there are specific procedures in place to be followed. Maintaining marketing authorisations in a global scenario is a challenge and requires strategic planning and a good knowledge of the different regulations and timelines. Efficient and smooth communication between GMP and Regulatory Affairs is a key factor of success.
Programme
What is a Regulatory Dossier? - Setting the Scene for the Training
- The ICH CTD guidance
- GMP data in the regulatory filings
- Regulatory filings as a basis for inspections
- Centralized procedure
- Decentralized procedure
- Mutual recognition
- National procedures
- Specific dossier requirements for different medicinal products
- Timelines
- Generic applications
- New Drug Application (NDA)
- IND procedure and special issues
- Abbreviated New Drug Application (ANDA) – Generics
- Pre-approval inspections
- Timelines and meetings with the FDA
- Regulatory requirements in Japan
- GMP regulations in Japan (J-GMP)
- Quality related aspects of the SmPC
- Clinical particulars
- Pharmacological properties
- Pharmaceutical particulars - Labelling
- Package leaflet
- Mock ups and specimen
- Quality experts, non-clinical and clinical experts
- Bibliographical applications
- Homeopathic applications
- Pediatric applications
- How to provide CMC Information
- What information is required in Module 3.2.S
- Differences in interpretation of the requirements
- Differences in format
- Procedures in the various regions: US, EU, Japan
- Medicinal product – documentation of quality in Module 3
- Impurities
- Stability data
- Container and closure systems
- Critical Parameters - Optimising the submission
- Risk-based approach in industry and regulatory authority
- Clinical study reports
- Efficacy and safety
- Clinical summary and clinical overview
- Non-clinical study Reports
- Toxicology
- Pharmacokinetics
- Safety studies – decision tree
- Toxicity studies to qualify impurities
- Non-clinical summary
- Critical points
- Types of inspections
- Essential PQS interfaces
- Change control from a GMP view
- Deviations from Marketing Authorisations
- Inspector’s planning, preparation, conduction and follow-up of GMP inspections
- EU-GMP regulations
- Technical terms of EU-GMP guidelines
- Basic requirements for GMP inspections
- Required authorizations, registrations, certificates and how to get them
- How to certify/release a batch?
- Which audits are on duty?
Handling Variations and Changes
- Why do we need to file changes?
- Handling changes within an API Company
- Impact of a change: categorization of changes
- Change procedures around the world: EU (ASMF and CEP), US, Japan
Further Information
Venue
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg, Germany
Phone +49 (0) 40 22 63 62 0
Email: hamburg@barcelo.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.
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
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:
Ms Anne Günster (Operations Director), +49 (0) 6221 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel (Organisation Manager), +49 (0) 6221 84 44 43, thiel@concept-heidelberg.de
Date & Time
(Registration/coffee 8:30 - 9:00 h)
Wed, 25 March 2026, 9:00 - 15:00 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
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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
