Pharma Package - Läkemedelsakademin

Pharma Package –
Pharmacovigilance in
the Nordic Countries
beyond June 2012
– a conference with the Nordic Pharmacy Industry
organizations and the Nordic Competent Authorities
11 October 2011, Stockholm, Sweden
w w w . l a k e m e d e l s a k a d e m in . s e
This will be a unique opportunity to meet colleagues and listen to
Regulatory Authority representatives and key actors in the field.
The aim of the conference is to clarify country specific requirements and understand the implementation of Pharma package,
Regulation 1235/2010 and Directive 2010/84/EU, in the Nordic
countries. Additionally, the conference intends to facilitate
interaction while participants share their individual experiences
in the field and questions for the future.
Who should attend?
Professionals who have an interest in Pharmacovigilance, Regulatory Affairs, Compliance and Risk Management and want an
update on the planning for the implementation of the New EU
PV Legislation in the Nordic countries.
Conference objectives
– To discuss the implementation of the New EU PV Legislation
and the impact it will have on Pharmacovigilance in the
Nordic region.
– To address specific issues of concerns and how to overcome
them.
– To offer a unique opportunity to interact and converse with
colleagues in the Nordic countries.
Speakers
Regulatory authority representatives with an in depth knowledge
of their respective countries and the EU/EEA preparations.
Representatives confirmed from Danish Medicines Agency,
Finnish Medicines Agency, Icelandic Medicines Agency,
Norwegian Medicines Agency, Swedish Medical Product Agency. Also participating: European Medicines Agency.
Organizers
The Research-based Pharmaceutical Industry in Sweden, Pharma Industry Finland, The Icelandic Association of the Pharmaceutical Industry, The Norwegian Association of Pharmaceutical
Manufacturers, The Danish Association of the Pharmaceutical
Industry and Swedish Academy of Pharmaceutical Sciences. Organizing committee:
Denmark: Lone Munk Hansen, Eli Lilly
Finland: Bengtström Mia, Pharma Industry Finland
Iceland: Jakob Falur Garðarsson, Frumtök – the Icelandic Association of the Pharmaceutical Industry
Norway: Kamilla Jendem, Novartis; Monica Kjeken,
LMI
Sweden: Emma Wiman, IRW; Johan Hellmér,
Baxter; Malin Nilsson, Sanofi Pastur MSD; Julia
Appelskog, Johnson & Johnson Consumer Nordic;
Anita Finne Grahnén, LIF Sverige; Anders Pesula,
Läkemedelsakademin
Time and Location
The seminar is held on October 11th in Stockholm,
Sweden. The seminar starts at 09.15 a.m. and ends
at 16.30 p.m.
The conference venue is World Trade Center
www.wtc.se/en, Klarabergsviadukten 70,
Kungsbron 1 in Stockholm.
Participation Fee
The participation fee is sponsored by the Swedish
Academy of Pharmaceutical Sciences. The fee includes certificate of completion, coffee and lunch is
SEK 2.600 before August 11th and SEK 3.900 after
that date.
All prices given excluding VAT.
Cancellations can be made at no charge up until 60
days before the start of the seminar. After this our
cancellation policy applies, which can be found on
the booking confirmation and on our home page.
Cancellations should be addressed in writing.
Contact Information
For further questions, please contact
the project assistant Kia Olsson,
kia.olsson@lakemedelsakademin.se
tel +46(0)8-723 50 51 or
the project manager Anders Pesula,
anders.pesula@lakemedelsakademin.se
tel +46(0)8-723 50 45.
(11620/aps)
Application, Confirmation, Cancellation
When register to the conference, you will receive a
booking confirmation via e-mail. If you are not able
to attend you may send another participant from the
same company at no additional charge if you inform
responsible Project Administrator.
Register at www.lakemedelsakademin.se
www.lakemedelsakademin.se/PVNordic
Last date for reduced delegate fee August 11, 2011!
Early registration is recommended!