Global Registration and Life Cycle Management for APIs

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