RESCHEDULED MEETING

Dear all,

This conference was postponed from 21-22 April 2010, due to the volcanic activity in Iceland and the associated travel disruptions.

Please do contact us on +41 61 225 51 51 if we can be of any further help.

With kind regards,
DIA Europe Team

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European legislation and guidelines such as Volume 9A require all marketing authorisation holders to have a Qualified Person for Pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company’s global pharmacovigilance system. Although acknowledged to be a vital function, there is little practical guidance on how QPPV responsibilities should best be conducted, while maintaining compliance with regulatory requirements, particularly in complex or challenging situations. The jurisdiction of the QPPV stretches to wherever there is an active licence for a product authorised in the EU. Thus the role in many companies has a far reaching impact outside the EU or may extend to products licensed by one or more affiliates or subject to co-marketing agreements. During this meeting we will discuss and draw on experience of handling these situations in the current complex environment to help QPPVs perform their job more efficiently.

• Identify the role and expectations of the role in the context of the proposed new regulatory framework and updates to Volume 9a and transparency initiatives
• Look at upcoming areas of real challenge for the QPPV such as mergers, outsourcing and complex marketing situations
• Advance understanding of the legal aspects and associated liabilities for the QPPV
• Learn about regulatory and inspectorate expectations of the QPPV
• Share experiences to learn better how to fulfil and deal with the role of the QPPV

DIA EUROPE

ELISABETHENANLAGE 25, POSTFACH

4002 BASEL, SWITZERLAND

PHONE: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

TRAVEL INFORMATION:
Edgware Road station, on the Bakerloo line and Circle line, is a five-minute walk to the hotel.

London Heathrow
Take the Heathrow Express rail link to Paddington station. The hotel is a five-minute walk from Paddington station or a short taxi ride.

London Gatwick Airport
Take the Gatwick Express train to Victoria station, change for the Circle line to Edgware Road station, which is 30 metres from the hotel entrance.

London City Airport
Take the DLR train to Canning town, change on to the Jubilee line to Baker Street and changeon to the Bakerloo line to Edgware Road station. Alternatively travel one hour by car.

For more details please visit: www.tfl.gov.uk

HOTEL INFORMATION:
The DIA has blocked a number of rooms at the:

Hilton London Metropole
225 Edgware Road
London W2 1JU, UK
www.hiltonlondonmet.com

at the special rate of:
£139 inclusive of breakfast, exclusive of VAT

To make your reservation please
Email: reservations.londonmet@hilton.com
Tel:     + 44 207 616 6570 

Please quote the booking reference: GDIAA

Important: Please complete your reservations by February 19, 2010

In case of cancellation:
Cancellation of hotel room bookings must be made in writing directly to the hotel 7 days prior to the arrival date. Cancellations made at least 7 days prior to arrival will not incur any cancellation charges. Any cancellation made less than 7 days prior to arrival will be subject to the first night being charged at the full agreed rate.
All no shows will be billed for the entire stay.
 

Group Discounts Available – Send 3 participants and the 4th is free!

Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.