The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.
Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.Why you should attend
This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.Who Will Benefit
- Regulatory Affairs
- Quality Assurance
- Project Management
- Regulatory Operations
- Anyone responsible for providing content for the CTD
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GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
- Risk Management
- Regulatory Compliances
- Corporate Governance
- Quality Management
Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. In the 10 years for which it has been in the professional trainings industry; GlobalCompliancePanel has developed a rich legacy of courses. It boasts an amazingly large repertoire of 5000 courses, which consist of over 2000 in-person seminars. ...