Having an electronic submission strategy in place is critical in supporting the transition to eCTD. Advanced planning and an understanding of eCTD submission requirements in the various regions are important steps in filing a successful electronic submission. With eCTD becoming the mandatory submission format in most major markets by 2017/2018, is your company ready to make the transition?
Whether you are looking for a software solution that helps you manage, view and publish your regulatory process or planning to outsource your regulatory submissions, this webinar will provide valuable insight.
The webinar covered:
- Learn about the current status of eCTD submissions in across major global markets
- Understand how you to optimize the management of your eCTD documents, with a global approach
- Learn tips for successful global planning, quality control and outsourcing of eCTD submissions
- Gain insights into outsourcing vs. in-house publishing
Experts from leading service and solution providers will share their experience through presentations and live demos.
About VCLS and LORENZ:
VCLS supports life science companies and engages in communication with regulators and payers to develop, register and launch innovative health products in global markets. VCLS partners with LORENZ Life Sciences Group, the global solution partner for Regulatory Affairs Software.
LORENZ docuBridge® is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike.
Elaine O’Callaghan, Director Regulatory Support
Elaine has over 8 years experience in ePublishing and developed the ePublishing group at VCLS. She provides assistance to International Clients with publishing strategy and submissions. She manages 50+ global applications including Initial MAAs, NDAs, BLAs, and INDs as well as LCM submissions, ASMFs and PSURs. She closely follows the evolution of eCTD and ICH guidelines and maintains VCLS’ internal eCTD Distinct Technical Procedures (DTP).