Abridged Applications

Management Forum

Course

In The Rembrandt Hotel, London

£ 699 + VAT

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Description

  • Type

    Course

  • Level

    Intermediate

  • Location

    The rembrandt hotel, london

  • Class hours

    8h

  • Duration

    1 Day

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

Facilities

Location

Start date

The Rembrandt Hotel, London (London)
See map

Start date

On request

About this course

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

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

A basic knowedge of the application procedure will be assumed.

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Subjects

  • Quality
  • Quality Training
  • Abridged
  • Management
  • Life Science
  • Pharma
  • Pharmaceutical Marketing
  • Regulations
  • EU Law
  • Training

Teachers and trainers (2)

Dr Anmar Marouf

Dr Anmar Marouf

Scientific Director at Inresa Arzneimittel GmbH, Freiburg, Germany.

Dr Patrick Salmon

Dr Patrick Salmon

Irish Medicines Board

Course 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

See related categories

Abridged Applications

£ 699 + VAT

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