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PC15083

This Compendium consists of materials submitted by the speakers that complement their presentations. We understand what an important resource this material is and we have made a concerted effort to secure biographical sketches, outlines and related materials.

Additionally, you will find included, helpful information on solution providers, publications and associations, including links their websites.

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Presentations

REMOTE PRESENTATION
EFPIA Address

Sini Eskola
Director, Regulatory Affairs
EFPIA

PANEL Successes and Lessons Learned from Early Adopters

Moderator:

Thomas Wicks
Chief Strategy Officer
TrialScope

Panelists:

Carlos Langezaal, Ph.D.
Director, Global Regulatory Affairs
Eisai Inc.

Stefan Ochalski
Senior Director, Global Regulatory Affairs
Janssen

Barbara Kress
Department Head, Trial Disclosure and Data Access
Merck

TOPIC INTENSIVE Ensure Foundational and Strategic Knowledge of the Existing CT Directive Prior to Transitioning to the New Regulation

Mark De Rosch, Ph.D.
Vice President, Regulatory Affairs
Akebia Therapeutics

Elisabeth Garrison
Senior Regulatory Science
Voisin Consulting

CASE STUDY Navigate the Transition from Voluntary to Mandatory Harmonization Procedures

Stefan Ochalski
Senior Director, Global Regulatory Affairs
Janssen

Automate EU Regulation Tracking, Scoping & Planning

Jack Yeager
Chief Executive Officer
Sylogent

Incorporate Monitoring and Safety Reporting Techniques into U.S. and EU Clinical Trial SOPs

Anita K. Murthy, PharmD
Deputy Director, Global Regulatory Affairs
Bayer Healthcare

INTERACTIVE ROUNDTABLE DISCUSSION Adapt Internal Roles and Responsibilities to Support the New Regulation

Juliette Kirk
Business Process Owner – Clinical Trial Applications
Pfizer

Best Practices for Transitioning Existing Trials to New Disclosure Processes

Thomas Wicks
Chief Strategy Officer
TrialScope

TOPIC INTENSIVE Examine the Requirements for Posting Clinical Trials on EudraCT (& EU Portal) — How Will Demands and Requirements Change?

Scott Patton
Associate Manager, Clinical Trials Disclosures
Gilead Sciences

INTERACTIVE DISCUSSION Manage Clinical Trial Redactions for Patient Privacy and Data Protection

Wendy Wimmer
Principal Scientist, Clinical Research
Merck

Speaker Bios

Mark De Rosch, Ph.D.
Vice President, Regulatory Affairs
Akebia Therapeutics

Elisabeth Garrison
Senior Regulatory Science
Voisin Consulting

Juliette Kirk
Business Process Owner – Clinical Trial Applications
Pfizer

Barbara Kress
Department Head, Trial Disclosure and Data Access
Merck

Carlos Langezaal, Ph.D.
Director, Global Regulatory Affairs
Eisai Inc.

Anita K. Murthy, PharmD
Deputy Director, Global Regulatory Affairs
Bayer Healthcare

Stefan Ochalski
Senior Director, Global Regulatory Affairs
Janssen

Scott Patton
Associate Manager, Clinical Trials Disclosures
Gilead Sciences

Thomas Wicks
Chief Strategy Officer
TrialScope

Wendy Wimmer
Principal Scientist, Clinical Research
Merck

Jack Yeager
Chief Executive Officer
Sylogent

  Agenda
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TrialScope Sylogent Kinapse Xogene Synchrogenix

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