Marketing authorisation & lifecycle management

Detailed programme Day 1: 09:00 am - 05:00 pm
Day 2: 09:00 am - 04:00 pm 09:00 Opening and introduction round
09:15 Francijn Oom The legal basis for marketing authorisation in Europe

The need of MA approvals

Involved authorities, reg. framework

Full application, bibliographic application, mixed application and informed consent

Generic application, hybrid application and biosimilars

Registration

Available procedures at a glance

When to use which procedure?

11:00 Coffee break
11:15 Freliza van der Plas Mutual recognition and decentralized procedures in detail

Common principles

Submission strategy

Deadlines and clock stops

Strategic aspects

Where are the issues?

13:00 Lunch break
14:00 Camilo Molina Centralised procedure

Scope and mandatory products

Roles: EMA, CHMP, national authorities

The procedure in detail

15:30 Coffee break
15:45 Lidia Cánovas Specifics for generics

Data exclusivity, innovation protection

European reference product

17:00 End of training day I
09:00 Ingrid Prieschl Variation system and procedure

Variation Regulation, Classification Guideline

Type IA/B notifications and Type II variations: Correct classification

Article 61 (3) notification

Classification with practical examples

Procedural aspects and timeline

Grouping and worksharing