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: How to Defend their Choice in a Submission

• 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

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

Registration Procedures in the US and Japan – what are the Differences?

• 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

Top ten Deficiencies in new Applications for Certificates of Suitability for Chemical Purity
Alma Kiso

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: in the EU, US and Rest of the World

• 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