Regulatory Submissions, Information, and Document Management Forum

返回 Agenda

Session 10 Track 3: How Innovative Collaboration Supports Compliance Across the Regulatory Ecosystem

Session Chair(s)

Karen McCarthy Schau

Director, Risk-based Study Management

Vertex Pharmaceuticals, United States

The way industry works with health authorities has not changed significantly since the introduction of electronic submissions and has impacted communications and responsibilities across functions. This session will explore ways sponsors can achieve both greater control and compliance as well as improving their way of working together with health authorities to expand access to medicines.

Learning Objective : At the conclusion of this session, participants should be able to:
Outline the collaborative benefits for compliance using a BDL solution
Explain how the organization can better collaborate with Health Authorities during the review process
Identify if their organization is ready to explore structure content authoring

Speaker(s)

Compliance through Collaboration Using a Single Business Development Lifecycle Management Tool

Paul Cutajar, MA

Merck & Co., Inc., United States

Director, Innovation & Information Management

Preparing Your Organization for Transitioning a Digital Dossier

Sarah Powell, RAC

Powell Regulatory Services, United States

President

Working with Health Authorities - The Art of the Possible

Dominique Lagrave, PharmD

Accumulus Synergy, United States

Senior Vice President of Regulatory Innovation