Summit will explore the electronic submission process and protocols for IDMP, RIM, global, and regulatory submissions.
ExL Events, a developer of educational conferences that serve the pharmaceutical and allied healthcare communities, is hosting a 2017 eRegulatory Submissions Summit, July 10-11, 2017 at the Sheraton Philadelphia University City in Philadelphia, PA.
The conference will cover electronic submissions processes to construct strategies for the identification of medicinal products, regulatory information management, and global and regulatory submissions.
Electronic submission guidelines and new standards for submissions will be reviewed.
“I cannot remember a time in my career when the regulatory submissions landscape has been confronted with this many evolving regulatory changes, trends and challenges,” said Olga Alfieri, Director, Global Submission Management at Eisai, and chair of the event.
The conference will feature participants from Celgene, Teva, Lycera, Bristol-Myers Squibb, Eisai, and other companies with speakers on tap to address regulatory updates during sessions and panels.
Featured speakers include:
- Catherine Burgess, Senior Director, Emerging Markets Regulatory Affairs and Global Regulatory Affairs, Takeda
- Linda Chong, Manager, Global Regulatory Operations, Celgene
- Sabrina Girty, Vice President, Regulatory Affairs, Lycera
- Shelly Grasse, Regulatory Administrator, Lycera
- Alexis Harper, Global Head of Submission Portfolio Management, UCB
- Stephanie Hughes, Regulatory Submissions Management Associate, Teva
- Adam Ivans, Submission Manager, Bristol-Myers Squibb
- Michael Sauter, Senior Director Regulatory Operations and Global Labeling, Mallinckrodt Pharmaceuticals
- Heather Sinsel, Manager, Regulatory Operations and Submissions, Inovio Pharmaceuticals
- Marc Stern, Director, Regulatory Processes, Operations and Publishing, Eagle Pharmaceuticals
- Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, Rutgers University
Other eRegulatory Submissions Summit sponsors and supporting partners include Jack Yeager, CEO, Sylogent.
ExL Events is a division of Questex, LLC, serves pharmaceutical and related fields in a variety of markets, including the United States, Europe, and Latin America.