Speakers


Marieke van Dalen
MARA Consultancy

Cristina Jimenez Sala
Centrient Pharmaceuticals

Alma Kiso
European Directorate for the Quality of Medicines (EDQM & Health Care)
Objectives
Participants will have the opportunity to take part in 2 workshops:
- Stability studies and establishing a retest date
- Description of the manufacturing process
Background
- Certificate of Suitability of the pharmacopoeial monograph (CEP)
- Full details of manufacture (according to CTD Module 3 Quality of Drug Substance)
- European Active Substance Master File (ASMF; former Drug Master File, DMF)
- Other evidence of suitability of the pharmacopoeial monograph
Target Group
Date / Venue / Presentations / Certificate
Tuesday, 21 April 2026, 09.00 – 17.30 CEST
(Registration and coffee 8.30 – 9.00)
Wednesday, 22 April 2026, 09.00 – 17.30 CEST
Thursday, 23 April 2026, 08.30 – 15.00 CEST
Venue
NH Collection Heidelberg
Bergheimer Straße 91
69115 Heidelberg, Germany
Phone: +49 6221 1327 0
eMail: nhcollectionheidelberg@nh-hotels.com
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.
Programme

Seminar Programme as PDF
Dossier Requirements for the Drug Substance – An Introduction
- Chemical pharmaceutical documentation for active substance(s) – Regulatory requirements in EU and USA
- Types of active substances – types of documentation
- CTD Module 3, CEP and ASMF
- CEP for a substance for TSE risk assessment
Requirements for the Certificate of Suitability to the European Pharmacopoeia
- CEP Procedure: legal framework, the role, place and scope
- How the CEP procedure works for new CEPs
- Basic principles for maintaining the CEP: administrative, minor and major changes, renewal of CEPs
- Key figures and how to communicate with EDQM
The European Active Substance Master File Procedure
- Regulatory background and scope
- The revised European ASMF Guideline
- Applicant‘s and restricted parts - points to consider
- Questions & answers on the ASMF procedure
- Recent European developments: Sharing of assessment reports, data bases ….
Pharmaceutical Impurities: Residual solvents, synthesis-derived and genotoxic and elemental impurities
- CPMP-/ICH-Guidelines on Impurities and Residual Solvents
- ICH M7 Guideline on genotoxic impurities
- ICH Q3D(R1) Guideline on elemental impurities
- Specifying impurities
- Classifying solvents, setting and proving limits
- Justification of specification
- CPMP/ICH Guidelines
- Stability Summary and Conclusions, stability commitment
- Documentation of Stability Data
- Necessity for documentation of raw data?
- How to interpret information laid down on CEP-practical examples
- Project CEP 2.0: What has changed and what are the benefits?
- CEP holders’ responsibilities towards their customers
- How to use a CEP in marketing authorization application
API Regulatory Starting Materials
- Why is this such a hot Topic
- What guidelines to consider
- How to define a suitable starting material
- How to defend your choice in the Submission
- What is different for generics
- Consequences of a redefinition
- CEP process overview with focus on technical validation at reception
- How to build up a successful dossier and avoid deficiencies
- Top 10 most frequent question raised after the initial assessment of new applications for CEP with practical examples
- Expectations and recommendations on how to address the specific deficiencies with reference to applicable Guidelines
Comparison of the CEP and DMF Procedure
- Advantages of the CEP procedure
- Handling changes
- In which countries is the CEP being accepted?
- Cost Considerations
- Practical examples
Regulatory Procedures in the US and Japan
- Overview of the procedures
- Specifics for US and Japan
- How does the EDQM inspection procedure work
- EDQM GMP Assessment tools: On-site inspections, documentation-based GMP Assessment and Real Time Remote Inspections (RTEMIS)
- Inspection facts and figures
Stability Studies and Establishing the Retest Date
Cristina Jimenez Sala
Description of the Manufacturing Process
Dr Wilhelm Schlumbohm
Important: In order to prepare the lectures and the workshops in an optimal way, please send your questions to special topics to Ms Anne Günster, guenster@concept-heidelberg.de. She will forward your questions to the responsible speaker. Thank you in advance for your cooperation.
- General remarks on API registrations in Emerging Countries
- Details of API registration in:
- Taiwan
- India
- CIS countries: Russia, Belarus, Ukraine
- GCC countries
- APIC Emerging Countries Interest Group
- Overview of the procedures
- Specifics for Brazil and China
- Experiences
Variations/Changes and Life Cycle Management
- Types and categories of API changes
- EU: the variation regulation and CEP revisions
- Handling API changes in the US
- Handling API changes in Japan
- Handling API changes outside these regions
- Initiatives to facilitate changes
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
ECA-Member*: | € 2290,- |
Non ECA Member*: | € 2490,- |
EU/GMP Inspectorates*: | € 1245,- |
APIC Member Discount*: | € 2390,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
