Agenda
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Day 1 - Thursday, June 25, 2020
7:15 |
Registration and Continental Breakfast |
8:00 |
Co-Chairs’ Remarks |
8:15 |
The EMA and Related European Regulatory Bodies: Exploring Their Unique Roles, Interplay, and Significance to the Global Pharmaceutical Industry |
9:15 |
Examining the Status of “Brexit” and its Effects on Life Sciences Regulations Throughout Europe |
10:15 |
Morning Coffee Break |
10:30 |
The Nature of the Drug Approval Process in Europe via Centralized Procedure and Other Methods |
11:30 |
Understanding EU Clinical Trials and Procedures |
12:30 |
Networking Luncheon |
1:30 |
Demystifying the Patent/Regulatory Interface in the EU: Generic Approvals, Exclusivities and More |
2:30 |
Afternoon Coffee Break |
2:45 |
Biosimilars: A Study of Follow-On Biologics in the EU |
3:45 |
cGMPs in the EU |
4:45 |
Adverse Events Monitoring, Pharmacovigilance Protocols, and Recalls in the EU |
5:45 |
Boot Camp on European Pharmaceutical Regulatory Law Concludes |
Day 1 - Thursday, June 25, 2020
7:15 |
Registration and Continental Breakfast |
8:00 |
Co-Chairs’ Remarks |
8:15 |
The EMA and Related European Regulatory Bodies: Exploring Their Unique Roles, Interplay, and Significance to the Global Pharmaceutical Industry
|
9:15 |
Examining the Status of “Brexit” and its Effects on Life Sciences Regulations Throughout EuropeIt appears imminent that Great Britain, once the home of the EMA will leave or exit the European Union. This event–while still pending–will have a huge and game changing impact on the life sciences industry. This session will explore measures already put in place and well as those anticipated to prepare for the effects of Brexit.
|
10:15 |
Morning Coffee Break |
10:30 |
The Nature of the Drug Approval Process in Europe via Centralized Procedure and Other Methods
|
11:30 |
Understanding EU Clinical Trials and ProceduresEU Clinical Trials Directive
General Data Protection Regulation (GDPR)
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (GCP)
EU Good Clinical Practice (GCP) Directive
|
12:30 |
Networking Luncheon |
1:30 |
Demystifying the Patent/Regulatory Interface in the EU: Generic Approvals, Exclusivities and More
|
2:30 |
Afternoon Coffee Break |
2:45 |
Biosimilars: A Study of Follow-On Biologics in the EU
|
3:45 |
cGMPs in the EU
|
4:45 |
Adverse Events Monitoring, Pharmacovigilance Protocols, and Recalls in the EUAdverse Events/ PharmacovigilanceClinical
Post-Clinical
Recalls
|
5:45 |
Boot Camp on European Pharmaceutical Regulatory Law Concludes |