Date and place

Thu 03.09.2020 09:00 - Mon 30.11.2020 12:00
Duration: 89 days
WEBINAR, 00000, Helsinki

Hinta

425.00€
(+ VAT)

The Nordic Regulatory Affairs Seminar 3 September brought the Nordic authorities and pharmaceutical industry operators together to discuss the hottest topics. In this webinar you will see the whole seminar and get slides of the speakers. Length: appr. 5 hours.

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.

Programme


Welcome and introduction

Moderator: Laura Merisaari, Regulatory Affairs Manager, Bayer Oy


FUTURE OUTLOOK


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


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

 

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

 

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

 

UPDATE FROM THE NORDIC AUTHORITIES

Moderator: Pasi Virta, Responsible Pharmacist, Pfizer

 
● 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  

 

Finnish Medicines Agency Fimea
Päivi Jutila, Coordinator for Marketing Authorisations, CMDh Member 

 

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

Norwegian Medicines Agency
Dag Jordbru, Strategic Director, Safe Use   


Notifications of Medicine Shortages in Vnr Service
Essi Kariaho, Director, Pharmaceutical Information Centre


DISCUSSION, QUESTIONS AND ANSWERS
Moderator: Pasi Virta, Responsible Pharmacist, Pfizer Finland
Participants: Nordic Authorities & other speakers & the audience


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


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 webinar has been recorded 3rd September 2020. It's length is appr. 5 hours. You can order the webinar until 30th November. It is available for you 1 month after the order. 

 

Price


Webinar price EUR 425 + VAT. The price includes electronic training materials


Is there a group of interested colleagues Ask for a group discount from your event contact!

Further information and registration



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

The streaming of this seminar is funded by Nordplus Horizontal Programme.