Aika ja paikka

To 03.09.2020 kello 08:30-16:00
Kesto: 1 päivä
Clarion Hotel Helsinki, Tyynenmerenkatu 2, 00220, Helsinki

Hinta

495.00€
(+ alv)
Clarion Hotel Helsinki, Tyynenmerenkatu 2 Helsinki 00220

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 conference. We welcome participants from pharmaceutical companies, pharmaceutical industry associations, national competent authorities, contract research organizations and consultants.

Programme


8:30 Registration and coffee, networking


9:30 Welcome and introduction


Chairperson: Laura Merisaari, Regulatory Affairs Specialist, Oriola


FUTURE OUTLOOK


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


10:20 Charting New Waters: Taking a CAR-T to Sea
Geneviève Le Visage, Head of RA EU Policy and Liaison, Novartis Pharma AG


11:05 Lunch break & networking


12:05 Artificial Intelligence in Regulatory Affairs
The speaker will be confirmed soon


12:45 UPDATE FROM THE NORDIC AUTHORITIES

Chairperson: Pasi Virta, Responsible Pharmacist, Pfizer Finland


● Topical information on marketing authorizations
● Topical information on availability of medicines and solutions to shortages
● Cooperation with the EMA


Speakers will be confirmed soon


14:30 Coffee Break


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


15:15 DISCUSSION, QUESTIONS AND ANSWERS


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


16:00 Summary and end of the seminar
Chairperson: Pasi Virta, Responsible Pharmacist, Pfizer Finland


Programme is subject to changes

About the event


The event will be held from 8.30 am to 4.00 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 120 participants, so book your seat soon!


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.

Price


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: koulutus@laaketietokeskus.fi

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 at Clarion Hotel Helsinki 


Address:
Tyynenmerenkatu 2, 00220 Helsinki


Making reservation from the allocation:
When making a reservation from this allocation, kindly contact Inhouse Sales via email at reservations.cl.helsinki@choice.fi or via tel. +358 10 850 3820.


Kindly mention the allocation name RA2020 when making the reservation.


Prices:
Standard room for single use 136€/night
Standard room for double use 156€/night


Arriving to the hotel:
We recommend you arrive with public transportation, tram stop called "Huutokonttori" is located immediately in front of the hotel. Tram lines numbers 7, 9 and 6T will bring you to the hotel from the Helsinki Main Railway Station. Ruoholahti metro station is approximately 700 m away from the hotel.


If you will be arriving by car, parking is available at a local under-ground garage (Rokkiparkki, address Välimerenkatu 12) located approximately 400 m away from the hotel. QR-code can be collected from the hotel reception. Day fee 17€ / car and overnight 27€ / car. Exit is possible only after the QR-code has been paid at the hotel.