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Agenda

Understand Impending Changes for Harmonised Submission and Assessment Requirements

March 6-7, 2018
  • Brussels, Belgium

Agenda

Want more agenda details? Download the brochure.

DAY ONE
Tuesday, 6 March 2018

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Moira Daniels
Head of Regulatory Operational Excellence, VP, Global Regulatory Affairs
UCB

Important Considerations for Establishing
Processes to Support the Clinical Trial
Regulation, Including Lay Summaries

8:45

Examine the EU Clinical Trial Portal and Database from the Sponsor’s Perspective

Christopher Price
Manager Global Regulatory Affairs Oncology
Merck KGaA

9:30

Understanding Clinical Trial Regulation Transparency Provisions and Their Implementation Processes

Matthias Zerm, Ph.D.
Global Clinical Development
Lead Expert Clinical Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH

10:15

Networking and Refreshment Break

10:45

Best Practices for Establishing a Successful Lay Summary Process

Behtash Bahador
Senior Manager, Quality and Compliance, Communicating Trial Results
Center for Information & Study on Clinical Research Participation (CISCRP)

11:30

Create a Framework for Adverse Event Reporting Under the Regulation

Josefine Sommer
Associate
Sidley Austin LLP

12:15

Networking Luncheon

13:30

CTR, MDR and GDPR — The Big Bang of New EU Regulations Impacting The
EU Clinical Regulatory Landscape

Cristiana Spontoni
Partner
Jones Day

Case Examples of Work in Progress

14:15

Connecting the Dots — A UK Patient Perspective on the EU Clinical Trial Regulation

Richard Stephens
Consumer Lead, Chair of Consumer Forum
National Cancer Research Institute (NCRI)

15:00

Networking and Refreshment Break

15:30

Discuss Opportunities Resulting from Implementation of Global Standards

Tania Snioch
Director of Healthcare
GS1

16:15

CASE STUDY A Featured Look at Belgium’s Pilot Program

Greet Musch, Ph.D.
General Director Pre-Marketing Authorisation
Federal Agency for Medicines and Health Products (FAMHP), Belgium

17:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO
Wednesday, 7 March 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Moira Daniels
Head of Regulatory Operational Excellence,
VP, Global Regulatory Affairs
UCB

Benefit from an EFPIA Address
and Legal Perspective

9:00

EFPIA ADDRESS Critical Update on Regulatory Guidelines

Sini Eskola
Director Regulatory Affairs
European Federation of Pharmaceutical Industries and Associations (EFPIA)

9:45

EU Clinical Trial Data Transparency — General Legal Principles

Maurits Lugard
Partner
Sidley Austin LLP

10:30

Networking and Refreshment Break

Explore the Future Landscape

11:00

CO-PRESENTATION Evaluate the Impact of Brexit on the Clinical Trial Regulation

Matt Cooper
Business Development & Marketing Director
NIHR Clinical Research Network Coordinating Centre

Richard Stephens
Consumer Lead, Chair of Consumer Forum
National Cancer Research Institute (NCRI)

11:45

A Future Outlook on Clinical Trial Regulations — What’s Next?

Anastassia Negrouk
Head of International Regulatory and Intergroup Unit
European Organization for Research and Treatment of Cancer (EORTC)

12:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE
Tuesday, 6 March 2018

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Moira Daniels
Head of Regulatory Operational Excellence, VP, Global Regulatory Affairs
UCB

Important Considerations for Establishing
Processes to Support the Clinical Trial
Regulation, Including Lay Summaries

8:45

Examine the EU Clinical Trial Portal and Database from the Sponsor’s Perspective

Christopher Price
Manager Global Regulatory Affairs Oncology
Merck KGaA

9:30

Understanding Clinical Trial Regulation Transparency Provisions and Their Implementation Processes

Matthias Zerm, Ph.D.
Global Clinical Development
Lead Expert Clinical Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH

10:15

Networking and Refreshment Break

10:45

Best Practices for Establishing a Successful Lay Summary Process

Behtash Bahador
Senior Manager, Quality and Compliance, Communicating Trial Results
Center for Information & Study on Clinical Research Participation (CISCRP)

11:30

Create a Framework for Adverse Event Reporting Under the Regulation

Josefine Sommer
Associate
Sidley Austin LLP

12:15

Networking Luncheon

13:30

CTR, MDR and GDPR — The Big Bang of New EU Regulations Impacting The
EU Clinical Regulatory Landscape

Cristiana Spontoni
Partner
Jones Day

Case Examples of Work in Progress

14:15

Connecting the Dots — A UK Patient Perspective on the EU Clinical Trial Regulation

Richard Stephens
Consumer Lead, Chair of Consumer Forum
National Cancer Research Institute (NCRI)

15:00

Networking and Refreshment Break

15:30

Discuss Opportunities Resulting from Implementation of Global Standards

Tania Snioch
Director of Healthcare
GS1

16:15

CASE STUDY A Featured Look at Belgium’s Pilot Program

Greet Musch, Ph.D.
General Director Pre-Marketing Authorisation
Federal Agency for Medicines and Health Products (FAMHP), Belgium

17:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO
Wednesday, 7 March 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Moira Daniels
Head of Regulatory Operational Excellence,
VP, Global Regulatory Affairs
UCB

Benefit from an EFPIA Address
and Legal Perspective

9:00

EFPIA ADDRESS Critical Update on Regulatory Guidelines

Sini Eskola
Director Regulatory Affairs
European Federation of Pharmaceutical Industries and Associations (EFPIA)

9:45

EU Clinical Trial Data Transparency — General Legal Principles

Maurits Lugard
Partner
Sidley Austin LLP

10:30

Networking and Refreshment Break

Explore the Future Landscape

11:00

CO-PRESENTATION Evaluate the Impact of Brexit on the Clinical Trial Regulation

Matt Cooper
Business Development & Marketing Director
NIHR Clinical Research Network Coordinating Centre

Richard Stephens
Consumer Lead, Chair of Consumer Forum
National Cancer Research Institute (NCRI)

11:45

A Future Outlook on Clinical Trial Regulations — What’s Next?

Anastassia Negrouk
Head of International Regulatory and Intergroup Unit
European Organization for Research and Treatment of Cancer (EORTC)

12:30

Close of Conference