Aika ja paikka

To 03.09.2020 kello 08:30-16:15
Kesto: 1 päivä
Leonardo Da Vinci Auditorium , Itämerenkatu 11-13, 00180, Helsinki


(+ alv)
Leonardo Da Vinci Auditorium Helsinki 00180

The Nordic Regulatory Affairs Seminar will bring the Nordic authorities and pharmaceutical industry operators together to discuss the hottest topics! Come to the event or participate via the live webinar.

Participate in topical discussions, meet with your colleagues and network with industry partners. If you are unable to attend, you can participate in the live webinar or watch a recording of it later. We would like to warmly welcome you to the event!

Who should attend?

Professionals who have an interest in regulatory affairs, quality and supplier chain with an EU/Nordic focus will benefit from attending the seminar. We welcome participants from pharmaceutical companies, pharmaceutical industry associations, national competent authorities, contract research organizations and consultants.


8:30 Registration and coffee, networking

9:30 Welcome and introduction
Moderator: Laura Merisaari, Regulatory Affairs Manager, Bayer Oy


9:35 Marketing Authorisations in the EU - European Pharmaceutical Strategy and Implications in Practice
Sini Eskola, Director of Regulatory Affairs, EFPIA

10:10 Charting New Waters: Taking a CAR-T to Sea
Geneviève Le Visage, Head of RA EU Policy and Liaison, Novartis Pharma AG


10:45  Break (20 min)

11:05 Artificial Intelligence in Regulatory Affairs
Nikolai Constantin Brun, Director of Division, Head of Medical. CMO. Division for Medical Evaluation and Biostatistics, Danish Medicine Agency


11:45 EMA's Current Topics: the European medicines agencies network strategy to 2025, current and future initiatives regarding stakeholder engagement, shortages and ePI
Juan García Burgos, Head of Public and Stakeholders Engagement Department, European Medicines Agency

12:15 Lunch break & networking

Moderator: Pasi Virta, Responsible Pharmacist, Pfizer Finland

● Current topics on marketing authorisations
● Current topics on availability of medicines and solutions to shortages
● COVID-19 Impacts and what we could learn for the future


The Finnish Medicines Agency Fimea
Päivi Jutila, Coordinator for Marketing Authorisations, CMDh Member 
(20 min)


Danish Medicine Agency
Nikolai Constantin Brun, Director of Division, Head of Medical. CMO. Division for Medical Evaluation and Biostatistics, Danish Medicine Agency
(20 min)


Swedish Medical Products Agency
Stefan Berggren, Deputy Director div. for Supervision - Head of Swedish Competence Center for Pharma in the Environment 
(20 min)


The Norwegian Medicines Agency
Speaker will be confirmed soon (20 min)

14:40 Coffee Break

15:00 Notifications of Medicine Shortages
Essi Kariaho, Director, Pharmaceutical Information Centre Ltd

Moderator: Pasi Virta, Responsible Pharmacist, Pfizer Finland

Topics for discussion include:

● EMA’s new requirements and reasons 
● Medicine shortages and electronic patient information leaflets
● Other solutions for managing shortages
● Good practices in notification procedures

16:15 Summary and end of the seminar
Moderators: Laura Merisaari, Regulatory Affairs Manager, Bayer Oy, and
Pasi Virta, Responsible Pharmacist, Pfizer Finland


About the event

The event will be held from 8.30 am to 4.15 pm Finnish time. Registration starts at 8.30 am. The programme starts at 9.30 am.


Come to the event or participate via the live webinar. Please note that there is only room for a maximum of 50 participants on the spot, so book your seat soon! Please inform us in the Registration form / Additional information, whether you will attend via webinar or in Helsinki.

If you wish to participate via the live webinar, you will be able to ask the speakers questions via the chat. You will also receive a recording of the webinar after the seminar, which will be available for one month.

Please note that event is subject to changes due to the COVID-19 situation.


Early Bird price EUR 495 + VAT valid until 23 July 2020. After that the price is EUR 595 + VAT. The price includes electronic training materials and catering.

Webinar price EUR 425 + VAT.

Is there a group of you coming? Ask for a group discount from your event contact!

Interested in visibility at the event?

Participate in the event’s exhibition, promote your services, network with industry operators and invite your key clients and partners! The aim of the exhibition is to support networking and partnerships between industry operators. Choose the exhibition package you are interested in:

Starter Package: EUR 1970 + VAT

A Starter Package will get you off to a good start by securing visibility for your company in the event’s marketing materials, an exhibition stand, and by participating in the seminar with your colleagues.

Super Package: EUR 2570 + VAT

The Super Package includes participation in the seminar for you and your colleagues, your company’s visibility in the event’s marketing materials, an exhibition stand, and free attendance for two of your clients or partners at the event.

Book your stand:

Exhibition Partners

Exhibition Partners

Further information and registration

Register to the event no latest than two weeks before seminar via the link to registration. If you are participating in the webinar, please state this separately in the Additional Information field on the registration form.

Please read the changes and cancellations policy before registering to the event on the website at: Instructions for participants.


Accommodation is booked on your own. Suggested hotel closest to the venue:

Clarion Hotel Helsinki, Tyynenmerenkatu 2, 00220 Helsinki

Hotel room reservations via Clarion Hotel website

By using code EVENTS Clarion Hotel offers -15% discount of the day price as long as there are available rooms.