3rd Nordic Pharmacovigilance Conference April 3, 2014 On 3 April 2014, Lif and Medicademy Denmark proudly host the 3rd Nordic Pharmacovigilance Conference. The conference is a unique opportunity to meet key actors from the Nordic national competent authorities and the Nordic pharma industry. Professional Programme Kl. 8.00 - 9.00 Registration and Coffee Kl. 9.00 - 9.15 Welcome and Introduction Karsten Lollike, Novo Nordisk A/S Kl. 9.15 - 10.15 Pharmacovigilance Legislation – EMA Perspective New legislation – where are we, where are we going – need for changes? Plans for the next six months New guidelines New IT systems New working groups Outcome of recent workshops (patient associations, HCP organizations and industry organizations) Franck Diafouka, EMA Kl. 10.15 - 10.25 Coffee/Tea Kl. 10.25 - 11.40 New Pharmacovigilance Legislation – NCA Perspectives Norway –RMPs & evaluation of educational material Tanja Holstad Løken, NOMA Finland – RMPs & evaluation of educational material Terhi Lehtinen, FIMEA Sweden –Risk Minimization and Risk Measurements Anna-Lena Berggren, MPA Denmark – Signal Detection Mona Vestergaard, DHMA Kl. 11.40 - 12.10 Panel Discussion Questions to the authorities from the audience Regulators from the five NCAs Kl. 12.10 - 13.10 Lunch Kl. 13.10 - 13.40 Highlights from the latest published GVP guidelines Speaker to be confirmed Kl. 13.40 - 14.40 New Pharmacovigilance Legislation – Industry Perspective Siri Tendal, Pronova – HQ small company perspective Gro Laier, Novo Nordisk A/S – HQ large company perspective Virpi Tollander, Roche OY – Affiliate perspective Kl. 14.40 - 15.00 Coffee/Tea Kl. 15.00 - 16.00 Pharmacovigilance Inspections – NCA and Industry Perspective Lisbeth Bregnhøj, DHMA Denmark Örjan Mortimer, Baxter, Sweden Kl. 16.00 - 16.30 Experiences with PRAC – status and perspectives Yui Ying, MPA, Sweden Kl. 16.30 - 17.00 Panel Discussion and Wrap up Afternoon speakers 3rd Nordic Pharmacovigilance Conference What Organizing Committee On 3 April 2014, Lif and Medicademy Denmark proudly host the 3rd Nordic Pharmacovigilance Conference. • The conference is a unique opportunity to meet key actors from the Nordic national competent authorities and the Nordic pharma industry. • • • Who should attend? The seminar is open for anyone interested in safety and pharmacovigilance, but the target audience is professionals in: • • • • • • Medicines agencies in the Nordic countries Pharmaceutical associations in the Nordic countries Pharmaceutical companies in the Nordic countries HQ and Affiliate Safety issues in the Nordic countries HQ and Affiliate Pharmacovigilance in the Nordic countries HQ and Affiliate involved in benefit/risk balance in the Nordic countries Seminar Chairs Karsten Lollike, Corporate Vice President, Novo Nordisk A/S, Denmark Helle Harder, Head of Department, Danish Health and Medicines Authority, Denmark • Finland: Mia Bengtström, PIF, Annikka Seitsalo, Novartis and Leo Niskanen, Fimea Norway: Monica Kjeken, LMI; Karen Marie Ulshagen, Legemiddelverket Sweden: Anita Finne-Grahnén, Lif Se, Johan Hellmér, Baxter and Kerstin Jansson, MPA Iceland: Jakob Falur Gardarsson, Frumtök and Guðrún Kristín Steingrímsdóttir, Lyfjastofnun Denmark: Karsten Lollike, Novo Nordisk A/S, Helle Harder, Danish Health and Medicines Authority, Gro Laier, Novo Nordisk and Ulla Høegh, Lif Denmark Language English Price DKK 3,000,- + 25% VAT before 1 March 2014 DKK 3,500,- + 25% VAT after 1 march 2014 Exhibitor Information During the 3rd Nordic Pharmacovigilance Conference we offer companies an exhibition package at a price of DKK 5000 + VAT.All stands come equipped with a power socket, a bar table and a place for the exhibitor’s roll ups. The fee also includes a complimentary registration for one company representative, including lunch and refreshments for the conference day. Contact Henrik Køhler Simonsen - [email protected] Medicademy Lersø Parkallé 101 2100 Copenhagen Denmark T: +45 39 27 60 60, E:[email protected] W:medicademy.net