The Implementation of Transversal Inspections

With this session we have found an excellent opportunity to group the expertise of the professional organizations BRAS and UPIP-VAPI (Organization of Pharmacists in Pharmaceutical Industry). Both organizations have established an outstanding position to assure the training of respectively quality and regulatory people in the pharmaceutical industry.
A peek on competent authorities’ inspections in the future is therefore an ideal topic while both quality and regulatory departments will become strongly involved in their preparation and follow-up.
We strongly hope that this session will be a kick-off for a fruitful cooperation between the two organizations and that we can optimize the educational level of all our members.

This BRAS afternoon session will take place on Tuesday 26 June 2012 at the Montil, Affligem, from 13h30 to 17h15 (in Dutch and French, slides in English).

If you have specific questions on the subject, please send these to bras@bras-org.be and we will forward these to the Agency so that the speakers can include your questions in their presentations.

Programme and Speakers:

13.30 Introduction BRAS - UPIP-VAPI
Introduction Collaboration BRAS & UPIP-VAPI
(Marian Coquel - BRAS + Philippe Van der Hofstadt – UPIP-VAPI)
Introduction Seminar (Hugues Haesebroek - BRAS + Jo Dalle – UPIP-VAPI)

13.45 DG Inspection: A general overview - Josiane Van der Elst
How did the DG Inspection evolve over the last years?
What are the strategic pillars of the department?

14.15 The Past: A huge knowledge: A look back: 1970 - …
From Pharmaceutical inspection to Agency – Some milestones - Robert Delattin
The evolution of the DG Inspection – Some details

14.45 The Future: New concepts based on the actual reality - Karin Froidbise
Current Working method
Frequency and diversity of current inspections
New concepts: Team inspection, Transversal inspection, Risk Analysis, Auto-control
Definitions and explanation
Consequences

15.15 Coffee Break

15.45 From Theory to Practice
The empowerment of the various actors in the Pharmaceutical Industry: A win-win

I. EUDRAGMP Database – It’s all in the name (10 Min.) - Robert Delattin
   What does contain the database?
   Live demonstration of the database and its capabilities

II. Communication Lines Between Industry and Agency: (10 Min.) - Robert Delattin
    How to clarify/simplify the various contact points at the Agency?
    How to establish more effective communication lines?

III. FAQ - Frequent Audit Findings (40 Min.) - Karin Froidbise
     Anonymized frequent audit findings – What does the Agency expect?

16.45 Questions & Answers

17.15 Closing (BRAS – UPIP-VAPI)

Fees : Bras member € 150,00
            Non BRAS members € 350,00

Presentations in Dutch, French and English