How CORONA has changed the regulatory affairs world

Detailed programme from 09:00 - 16:00 Introduction and technical warm-up
Prof. Andrea Laslop Rolling submission and rolling review: An isolated case or a model for new, innovative medicines in Europe?

Innovative medicinal products in thecentralised procedure

What we have learnt from the firstCOVID-19 vaccine marketing authorisations

Discussion on future rolling submissions
Coffee break
Dr Ralf Wagner Specific regulatory requirements for the clinical exploration and licensing of prophylactic COVID vaccines
Discussion on clinical development issues
Lunch break
Dr Peter Bachmann Use of big data in regulatory affairs: Still a dream of the future?
Discussion on big data challenges
Short break
Dr Ulrich Granzer Good communication with the authorities and parallel advices: The key to success?

What information should be available in the advice?

How to proceed: When should the first advice take place and when should updates be submitted?

What is the best way to prepare within the company?

End of seminar

Detailed programme from 09:00 - 16:00 Introduction and technical warm-up
Prof. Andrea Laslop Rolling submission and rolling review: An isolated case or a model for new, innovative medicines in Europe?

Innovative medicinal products in thecentralised procedure

What we have learnt from the firstCOVID-19 vaccine marketing authorisations

Discussion on future rolling submissions
Coffee break
Dr Ralf Wagner Specific regulatory requirements for the clinical exploration and licensing of prophylactic COVID vaccines
Discussion on clinical development issues
Lunch break
Dr Peter Bachmann Use of big data in regulatory affairs: Still a dream of the future?
Discussion on big data challenges
Short break ...