Agenda

Day 1 Jun 11, 2018

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 9:00 AM

Q&A ON WEBINAR "EUROPEAN UNION – ROLE AND RESPONSIBILITIES OF EUROPEAN INSTITUTIONS. A COMPREHENSIVE OVERVIEW"

9:00 AM — 10:00 AM

LIFECYCLE OF A MEDICINAL PRODUCT

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 11:30 AM

LIFECYCLE OF A MEDICINAL PRODUCT CONTINUED

11:30 AM — 12:30 PM

EU LICENSING PROCEDURES – PART I

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

EU LICENSING PROCEDURES – PART I CONTINUED

2:30 PM — 3:30 PM

EU LICENSING PROCEDURES – PART II

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 4:30 PM

EU LICENSING PROCEDURES – PART II CONTINUED

4:30 PM — 5:00 PM

WHERE TO FIND WHAT / WHAT TO FIND WHERE?

5:00 PM — 6:00 PM

NETWORKING RECEPTION

Day 2 Jun 12, 2018

8:30 AM — 9:30 AM

VARIATIONS / POST APPROVAL CHANGES

9:30 AM — 10:30 AM

HANDS-ON WORKSHOP AND PRACTICAL EXAMPLES

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:00 PM

HANDS-ON WORKSHOP AND PRACTICAL EXAMPLES CONTINUED

12:00 PM — 12:30 PM

HARMONISATION & DEFINED MEDICINAL PRODUCTS

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 3:00 PM

PHARMACOVIGILANCE

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 4:00 PM

COMBINATION PRODUCTS

4:00 PM — 4:30 PM

KEY MESSAGES AND WHAT’S IN PIPELINE. QUESTIONS AND ANSWERS

Have an account?

Essentials and Overview of the Regulatory Framework in Europe

Agenda

Be informed and stay engaged.