GMP and Market Compliance Information Day 2008 - 23 October 2008
The Irish Medicines Board is pleased to host this one-day GMP and Market Compliance Information Day in Dublin. This event will cover various topics on the evolving GMP and regulatory requirements relating to the manufacture of medicinal products and active substances.
Agenda For Information Day
1. Opening Address -Pat O Mahony Chief Executive
2. GMP Update - Paul Sexton
3. PQR Overview And Feedback from Inspection - Lorraine Nolan
4. On-going Stability Programme - Victor Garvin
5. Self Inspection and its potential benifits via ICH Q9 & Q10 - Kevin O Donnell
6. Materials Management - Cormac Dalton
7. Annex 1 Revision - Greg McGurk
8. Manufacture of Sterile Medicinal Products - Ger Sheridan
9. PAT - Conor McSweeney
10. PAT - Chris Cullen
11. Important findings from a 2008 API Market Surveillance - Laura Hickey
12. QDR Programme - Key Aspects and Expectation - Aoife Farrell
13. API's - Cormac Dalton
14. EDQM Inspections of Foreign API Sites - Victor Garvin
Atypical Active Substances
Aims of the Seminar
This conference will address a number of key issues of general interest including:-
- Updates to the EU GMPs;
- Feedback from GMP inspection programme;
- Inspection expectations in key areas
In addition the afternoon programme will also include a number of sessions run in parallel which will cover more specialised topics relating to GMP and Market Compliance Activities. We would like to thank those that have registered, for their interest in the event, and we look forward to seeing you on the day. Some final details and clarifications in relation to the day are outlined as follows:-
Who Should Attend
This conference will be of interest to those working in quality assurance and control, regulatory affairs and compliance, legal services, training and production.
Two places will be allocated for each manufacturer’s licence holder or active substance manufacturer. Additional places will be assigned on a first come first served basis, pending availability.
Fee & Venue Details
The fee for this event includes course documentation, lunch & refreshments €300 for this one day conference
The Crowne Plaza Hotel, Northwood Park, Santry Demesne, Dublin 9
We have received a huge number of registration applications for this year’s event and unfortunately we are no longer able to accommodate further applications as we have reached full capacity.
Sincere apologies to those applicants that have been unsuccessful on this occasion, and we hope to see you at future events.
The final programme for the day is now available through the link on our website.
Registration on the Day
Registration on the day will commence at 7.30am. Attendees are advised to register as early as possible on the morning of the event, as the programme will start at 8.30am sharp. Tea, coffee and refreshments will be provided during registration.
Discussion and Questions
There will be time allowed for questions during the sessions. We do encourage attendees to actively participate in the discussion sessions on the day. This will increase the benefit for all in attending the event.
Further information on the event may also be obtained through contacting Silvia Vasilkova (email@example.com) at Compliance Department directly.