Regulatory submissions landscape has been confronting with many evolving regulatory changes, trends and challenges and it's important that regulatory professionals properly manage submissions. The regulatory submissions process can quickly become challenging when multiple team members are involved, and it is essential to ensure the quality and consistency of each document included in a submission.
The
2nd eRegulatory Submissions Summit will cover electronic submission processes and protocols for constructing strategies for IDMP, RIM, global and regulatory submissions. This summit will also address regulatory information management experiences and the proposed new standards for the identification of medicinal products and best practices for eCTD submission requirements.
Top Five Reasons to Attend
- Review EDMS Implementation for eCTD system
- Discuss submission management, regulatory project management, agency interactions, and time to market strategies
- Understand latest developments in ISO IDMP standards
- Gain a better understanding of the complexity of publishing eCTD
- Explore global and regulatory eCTD management and requirements
Who Should Attend
This conference is specifically designed for pharma, biotech and med device professionals responsible for:
- Regulatory Affairs
- Regulatory Writing/Medical Writing/Publishing/Information/Submissions
- Document and eRecords Management
- IDMP
- Business Operations/Processing
- Labeling
- Clinical Trials Management/Data
- Clinical Data
- Outsourcing/Clinical Outsourcing/Vendor Management
- Product Development
- Quality Assurance/Quality Control
This event is also of interest to:
- CROs
- Regulatory Specialists
- Regulatory Publishing/Regulatory Submission Software Designers
Speakers
- Olga Alfieri, Director, Global Submission Management, EISAI
- Robert Connelly, Senior Director, Product Management, SYNCHROGENIX
- S. Albert Edwards, President, S. ALBERT EDWARDS, PHARM.D., LTD
- Luke Everhart, Senior Specialist, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS
- Alexis Harper, Global Head of Submission Portfolio Management, UCB
- Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX
- Kelly Hnat, Vice President, IRISS FORUM
- Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS
- Deborah Satoh, Head of CMC Regulatory Submission, SHIRE
- Heather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS
- Marc Stern, Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS, INC.
- Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY
Please fill in your name and email to receive the conference agenda of this event.
Conference Day One - Thursday, July 12, 2018
Conference Day Two - Friday, July 13, 2018
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
Sonesta Philadelphia Downtown Rittenhouse Square1800 Market St.
Philadelphia, PA 19103
Explore the comfort and fresh, contemporary vibe at the all-new Sonesta Philadelphia. A premier choice among hotels in Philadelphia enjoys spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.
Relax and retreat in spacious accommodations. Treat yourself to a tasty bite, cocktails, and people watching at ArtBar. Go for a swim or lounge with a drink at our seasonal rooftop pool. Or wander through our gallery featuring the finest local artists around the city. Casual sophistication, impeccable service, and delightful added touches are what set us apart from Philadelphia Rittenhouse Square hotels.
To make reservations, please call 1.800.SONESTA and request the negotiated rate for ExL July Meetings. To make reservations online
Click HereThe group rate is available until June 20, 2018. Please book your room early, as rooms available at this rate are limited.
