Event Date: 25/02/2010 01:00
Presentations:
Quality Risk Management of the GDP Supply Chain - Cormac Dalton
Recalls and the Role of the Wholesaler - Aoife Farrell
Best Practices in Wholesale Distribution - Alfred Hunt
Feedback from GDP Inspection Programme - Catherine Neary
Tackling Counterfeit - Update - H.K. Bonar
Contracted Operations - Paula Dillon
Contracted Services - Alfred Hunt
Counterfeit Medicinal Products - Practical Strategies for Wholesalers - Lorraine Nolan
Distribution of Parallel Imported Medicinal Products - Lorraine Nolan
Parallel Imports - Authorisation Procedures - Conor O'Donovan
Update to the Exempt Products Notification System - Lynn Barr
Primary Distribution Activities - Paul Sexton
Cold Chain - Greg McGurk
Controlled Drugs Licensing and Reporting - Deirdre Ryan
Developments in GDP - Paula Dillon
Securing the Supply Chain for the Safe and Continuous Supply of Medicines - Monika Derecque-Pois
EU Legislative Proposals - H.K. Bonar
The Irish Medicines Board is pleased to announce that it will host a one-day seminar focusing on wholesale distribution of medicinal products for human use. The event will cover various topics on Good Distribution Practice (GDP) and the implications for the medicinal product supply chain with particular emphasis on the evolving regulatory requirements in this area.
We would like to thank those who have already 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:
Application Registration Close Out:
We would like to remind wholesalers, distributors and others interested in attending who have not already done so, to register immediately. We have received a huge response in terms of the number of attendees to date and plan to close out the application process by the close of business on Friday 19 February. Completed registration forms should be sent electronically to compliance.infoday@hpra.ie
Registration on the Day:
Registration on the day will commence at 7.45am. Attendees are advised to register as early as possible on the morning of the event, as the programme will start at 8.45am sharp.
Discussion 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. We would like to provide attendees with an opportunity to submit written questions, of relevance to the programme itinerary, in advance of the event. Questions may be submitted with immediate effect using the Interactive Discussion Points form. Completed forms should be emailed to compliance.infoday@hpra.ie. It will also be possible to submit questions during the course of the event itself.
Aims of the Seminar
The distribution sector is an area of the pharma-industry which is undergoing significant development and change. The sector has seen rapid growth, over recent years. This has resulted in increased complexity and the entry of many new stakeholder groups.
Due to the ever increasing threat posed by counterfeit medicinal products, the supply chain is an area currently undergoing extensive regulatory review at EU and international level. The outcome of this will be substantial change and increased application of regulatory requirements to this sector of the pharma-industry.
In line with these developments and the changing regulatory environment we intend to expand this popular information day to a full day programme. This will allow for an interactive meeting with full discussion of current issues from both a regulatory and industry perspective.
This seminar will address a number of key issues including:
- Counterfeit medicines / threats to the supply chain
- Regulatory developments to combat counterfeits
- Progress on updates to the EU GDPs
- Feedback from the GDP inspection programme / inspection expectations in key areas
- Risk based inspection strategy
- Market compliance activities
The programme will be structured to include presentation on topics of general interest in the morning.
The afternoon programme will consist of sessions run in parallel which will cover more specialised topics relating to GDP and market compliance activities.
For a more detailed agenda please click here.
Who Should Attend
This information day will be of interest to those working in the following sectors of the pharma-related industry: distribution and wholesale; logistics and storage including cold chain distribution; transportation; quality assurance; regulatory affairs and compliance; legal services; training.
Two places will initially be allocated for each wholesaler.
Additional places will be assigned on a first come first served basis, pending availability.
Fee & Venue Details
Fee:
€250 for 1-day conference
The fee for this event includes course documentation, lunch & refreshments
Venue:
The Crowne Plaza Hotel, Northwood Park, Santry Demesne, Dublin 9
Please contact the hotel directly if you are interested in booking accommodation on the night of the 24 February 2010.
Telephone: 01 8628888
Website: www.cpdublin-airport.com