Global Registration and Life Cycle Management for APIs
Get first-hand information about the CEP and the amended Variations Regulation.
11-13 May 2027, Barcelona, Spain
Course No. 22881
Speakers
Dr Wilhelm Schlumbohm
Berlin
Marieke van Dalen
MARA Consultancy
Cristina Jimenez Sala
Centrient Pharmaceuticals
Highlights - Dossier requirements for the drug substance and requirements for the Certificate of Suitability - ASMF procedure - Synthesis derived impurities, genotoxic impurities, elemental impurities and residual solvents - Choice and justification of the API starting material in a submission - Variations/changes and life cycle management and stability data - Registration procedures in the US, Brazil, China and Japan
Target Group
The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations who want to become familiar with the different ways to document the quality of the drug substance for the purpose of marketing authorisation in Europe. Furthermore, the course will be of interest to personnel from Quality Units of the medicinal products and the API industry.
Objectives
This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF. In this context the consequences of the guidelines on Elemental Impurities (ICH Q3D (R1)) and genotoxic impurities (ICH M7) will be considered. Furthermore, the impact of the amended Variations Regulation will be discussed.
Participants will have the opportunity to take part in 2 workshops:
Stability studies and establishing a retest date
Description of the manufacturing process
Programme
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 mutagenic 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
Stability Data
CPMP/ICH Guidelines
Stability Summary and Conclusions, stability commitment
Documentation of Stability Data
Necessity for documentation of raw data?
How to read and use a CEP / Implementation of CEP 2.0
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
Top ten Deficiencies in new Applications for Certificates of Suitability for chemical Purity
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
The EDQM Inspection Programme
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.
Country specific Requirements
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
Regulatory Procedures in Brazil and China
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
Further Information
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona, Spain Phone +34 (93) 503 53 00 sants@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.
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.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on all three 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.
Tuesday, 11 May 2027, 9:00-17:30 (Registration and coffee 8:30-9:00) Wednesday, 12 May 2027, 9:00-17:30 Thursday, 13 May 2027, 8:30-15:00 All times mentioned are CEST.
Testimonials
