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Press Release

One Day Abridged Applications Seminar: The Regulator and the Industry View - London, United Kingdom - November 15th, 2016 - Research and Markets

Research and Markets
Posted on: 05 Oct 16

Research and Markets has announced the addition of the "Abridged Applications" conference to their offering.

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

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


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

10.15 Bioequivalence – Studies

- When are they needed?

- BCS classification and Biowaiver

- Reference and test product

- Common problems and how to avoid them

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

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

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

17.30 End of Day

For more information about this conference visit

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Business Wire

Last updated on: 05/10/2016

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