Abridged Applications

Abridged Applications, The Regulator and the Industry view, an intensive course examing the current requirements and current problems for those with a basic knowledge of the application procedure.

Course overview

ABRIDGED APPLICATIONS – The Regulator and the Industry View

This seminar is concerned with the current aspects of abridged applications and will include information on any new issues arising in relation to these applications.

Safety, quality and efficacy will be addressed in an integrated fashion and the importance of application registration planning will be stressed.

A basic knowledge of the application procedure will be assumed

Why you should attend

TOPICS TO BE COVERED

  • The legislation associated with Abridged Applications
  • Paediatrics and Abridged Applications
  • Bioequivalence, BCS Classifications and Biowaiver
  • Clinical Issues and SmPC
  • Pharmaceutical and Quality Issues
  • Drug substance data, European drug master files and CEPs

Who should attend

  • Managing Directors
  • Research and Development Directors
  • Medical Directors
  • Clinical Research Managers and Clinical Pharmacologists
  • Research and Development and Registration Managers
  • Quality Assurance Managers
  • New recruits to registration
  • Regulatory and CMC Managers
  • New Recruits to Registration

Programme

09.00 Registration & Coffee

09.30 Introduction and the legislation associated with Abridged applications

  • The Current legislation: Directive 2001/83 as amended
  • The Mutual Recognition and Decentralised procedures
  • Centralised Procedures
  • Paediatrics and Abridged Applications
  • Problem areas with generic applications

Dr Patrick Salmon

10.15 Bioequivalence – Studies

  • When are they needed?
  • BCS classification and Biowaiver
  • Reference and test product
  • Common problems and how to avoid them

Dr Patrick Salmon

11.15 Refreshments

11.30 Pharmaceutical Quality Issues – 1

  • Drug substance data
  • Certificates of suitability (CEP)
  • European drug master files (EDMF/ASMF)
  • Pharmaceutical development for abridged products

Dr Anmar Marouf

12.45 Discussion

13.00 Lunch

14.00 Case Studies

15.15 Refreshments

15.30 Clinical Issues and SmPC

  • Review of data requirements: full versus abridged
  • Line extension
  • Bibliographical/Well Established Use
  • Generic products
  • Risk Management Plans
  • Biosimilars
  • Modified Release, Fixed Combination, Topical products

Dr Patrick Salmon

16.30 Pharmaceutical Quality Issues – 2

  • Manufacture and control of drug products
  • Manufacture process validation
  • Analytical Methodology and Validation
  • Stability testing of drug substance and drug products

Dr Anmar Marouf

17.30 End of Day

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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Previous customers include...

  • 3M Healthcare Ltd
  • Abbott Laboratories GmbH
  • Alliance Pharmaceuticals Ltd
  • Apotek Produktion & Laboratorier AB
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Disphar International B.V.
  • Fannin Limited
  • Galenicum Health SL
  • Genesis Pharmaceuticals
  • Guerbet
  • Infarmed
  • JensonR+ Ltd
  • Johnson & Johnson Limited
  • LEK Pharmaceuticals d.d.
  • Marlborough Pharmaceuticals Ltd
  • Medreich Plc
  • Merial SAS
  • Orion Corporation Orion Pharma
  • Oy Medfiles Ltd
  • PH&T SpA
  • Prime-Strategix
  • Pronova BioPharma Norge AS
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Rosemont Pharmaceuticals Ltd
  • Shire Pharmaceutical Ltd
  • UKR Regulatory Affairs Limited
  • Verfora SA
  • Weifa AS
  • Winthrop Pharmaceuticals UK Ltd
  • Zambon Group SpA