17 June 2014 - BRAS Session on the use of the Active Substance Master File (ASMF) - 13:30

Location :  De Montil, Affligem

In order to create a clear view on the do’s and don’ts of the creation and use of the Active Substance Master File (linked to module 32S of the CTD) we have invited both from industry (MAH and ASMF holder) and Competent Authorities perspective, eminent speakers to highlight the requirements, the pitfalls and the future of this difficult process. You can attend this exceptional session on 17 June, seats are still available.

Agenda and Speakers

13.30: Welcome and Introduction
            BRAS

13.45: ASMF holder perspective: current process -experiences and tips
            • Responsibilities of ASMF holder
            • Interactions with customers
            • ASMF reference number
            Yael Meynsbrughen, Karolien Verheyden (Ajinomoto OmniChem, Belgium)

14.30:  MA holder perspective: current process -experiences and tips
             • Responsibilities of MA holder
             • Differences in filing MAA vs ASMF
             Linda Vandeplas : (Janssen Pharmaceutica, Belgium)

15.15: Coffee break

15.45: Perspective from Competent Authorities:
            • the current process: what is working well and which are the common   
               mistakes (e.g. application form, format for ASMF submission, lacking ASMF 
               reference number, …)
            • the future process on ASMF worksharing (what will change, experiences from 
               the pilot…)
            Dr. Paul Marshall (MHRA, UK, Chairperson, Joint CMG Working Group on the 
            ASMF procedure)

16.45-17.00: Questions and Closing
                        BRAS

Presentations for this session will be given in English

Fees: BRAS member = 150€ - Non member = 350€

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 6 June 2014, the fees are due and will be invoiced.