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Key Legislation and Strategies for Complex-Generics
09.00
Review of Legislation for Generics EU and US definitions Legal Basis of Applications in EU / US
10.00
Understanding of Reference Products EU reference products European reference product US Orange Book (reference listed drugs)
10:30
Breakfast
11:00
Selection of Registration Procedure + Dedicated Workshop to Determine Key Influences for Selecting Procedure

  • EU Procedures
  • DCP / MRP
  • CP
  • US Procedures
  • ANDA

12.15
Strategy for Development of Complex Generics

  • Information Requirements
  • Target Product Profile
  • Quality Definition - Generic CQA’s

13:00
Lunch
14.00
Understanding Intellectual Property and Generics

  • EU Market Exclusivity
  • Data Exclusivity
  • US Exclusivity
  • Patent Strategies
  • Submissions under paragraph I to IV

15:00
Advanced product lifecycle management / Generics versus Brand

  • Life-cycle management
  • Product Data Management (PDM)
  • Product and portfolio management
  • Strategic analyses of product life cycle management
  • Development of Abridged Applications products with practical exercise.

16:15
Workshop - The Ten Stage Plan for Generics
Delegates will have the opportunity to create a development plan for super generics
17:00
Q & A
Module 3 Dossier and Application QbD
09.00
Global Dossier Requirements What’s new in CMC requirements
10.00
Regulatory Requirements

Overview of the ICH/FDA/EU guidelines on CMC requirements for biological products

10.30
Breakfast
11.00
Structure and Content of the CMC Sections of CTD

  • Module 1—GMP documentation for manufacturing facilities, CMC information in product labelling, information about CMC expert, etc.
  • Module 2—Quality Overall Summary, CMC information required Module 3—Drug Substance and Drug Product Sections Appendixes and Regional Information

12.15
Drug Substance Sections in CTD Dossier / Q11 Approach Open Part of the Drug Master File CTD Sections 2.3.S and 3.2.S
13.00
Lunch
14.00
Workshop - Key Information From Drug Substance Suppliers

Delegates will identify key questions for drug substance suppliers

15.00
Quality By Design

  • History
  • EU and US Expectations

15.45
Drug Product Sections in CTD Dossier (1)

  • Composition and data on components of the drug product
  • Pharmaceutical Development
  • Identifying CQAs
  • Understanding PAT
  • Understanding FMEA
  • The fundamental QbD Equation

16.15
Workshop - QbD Triangle

Delegates will identify the key linkages from materials to CQA’s using a unique QbD triangle process

16.45
The Equation of Module 3

Review criticality

17.30
Drug Product Sections in CTD Dossier (2)

  • Pharmaceutical Development (2)
  • Continuation of Module 3 and
  • The Application of QbD

09.00
Drug Product Section in Common Technical Documents (CTD)

Understanding the Manufacturing Section

10.30
Refreshments
11.00
Validation Data Requirements

  • Validation of manufacturing process.
  • Quality by Design principles
  • Validation of analytical methods

11.45
Drug Product Sections in CTD Dossier (3)

  • Product Specification
  • Analytical Methods
  • Linkage Between Section - Reviewers
  • Perspective

13.00
Lunch
14.00
Drug Product Sections in CTD Dossier (4)

  • Excipients
  • Packaging
  • Stability Data

15.30
Workshop - The R Test

Delegates will learn the key areas that should be addressed within the CTD Dossier for different product types

17.00
Latest Trends

  • Dossier Tips
  • ICHQ12

17.30
Q and A Session