Nordic Regulatory Affairs Meeting 2018 – Nordic Multilingual Packages for Human and Veterinary Medicinal Products

In co-operation with the Swedish Pharmaceutical Society and the scientific section of Regulatory Affairs together with the Medical Products Agency, Sweden.

The aim of the day is to discuss Nordic multilingual packages for human and veterinary medicinal products and highlight differences and similarities between the Nordic countries. The Nordic guideline on labelling- including FAQ - will also be discussed, and experiences from the Nordic Countries in relation to multilingual packs will be shared.

Confirmed Speakers

Alexios M. Skarlatos, European Medicines Agency, London, UK
Christelle Exbrayat, Merial SAS, Lyon, France
Elin Søndenå Sanne, The Norwegian Medicines Agency, Oslo, Norway
Jóhann M. Lenharðsson, Icelandic Medicines Agency, Reykjavík, Iceland
Lene Havsteen, Danish Medicines Agency, Copenhagen, Denmark
Niina Makkonen, Finnish Medicines Agency Fimea, Finland
Pia-Maria Grandell, Swedish Medical Products Agency, Uppsala, Sweden
Tobias Rydgren, Swedish Medical Products Agency, Uppsala, Sweden
Una Moore, Health Products Regulatory Authority, Dublin, Ireland
Victoria Ericsson, Astra Zeneca, Södertälje, Sweden
Ylva Satrell,  Swedish Medical Products Agency, Uppsala, Sweden

Moderator
Lena Vågberg, AstraZeneca, Gothenburg, Sweden

Who should attend?

Regulatory affairs professionals, quality assurance and compliance professionals, CROs and agency representatives.

Program

Preliminary program

Program Committee

Sylvia Packham, Swedish Academy of Pharmaceutical Sciences, Ylva Satrell, Swedish Medical Products Agency, Victoria Ericsson, AstraZeneca, Hedvig Maripuu, KRKA

Venue

The conference is held on May 3 2018 at World Trade Center, Klarabergsviadukten 70, www.wtc.se in Stockholm. The program starts at 09.00 hrs and ends at 17.00 hrs.

Participation fee

The registration fee includes lunch and coffee. Early registration (until March 26, 2018) 4.900 SEK Late registration (from March 27, 2018) 6.200 SEK Registrations are dealt with in the order of receiving. If seats are available, registration can be made until the start of the event. You will receive a confirmation upon your registration.

Cancellation

Cancellations should be addressed in writing and can be made at no charge until April 3.

Accommodation

Accommodation is booked on your own. Suggestions for hotel near the World Trade Center: Scandic Grand Central, Kungsgatan 70, in central Stockholm, Phone +46 8 512 520 00.