The eCTD has become the standard for numerous regulatory agencies around the world. Yet, regulatory authorities are reporting serious problems with the quality and consistency of many of the eCTD submissions they are receiving.
Rockville, MD (PRWEB) June 13, 2011
Regulatory agencies, including the US Food and Drug Administration (FDA) and other global health regulators are increasingly accepting, and in some cases requiring, regulatory submissions in the electronic Common Technical Document (eCTD) format. The Regulatory Affairs Professionals Society (RAPS) will host two workshops on eCTD submissions in July in Long Beach, CA. The introductory Preparing Compliant eCTD Submissions will be held 18–19 July, and Advanced eCTD Submissions will follow, 20–22 July. Both will be at Hyatt Regency Long Beach. Regulatory professionals looking to hone their eCTD skills may choose either workshop or participate in both for comprehensive training.
FDA’s Center for Drug Evaluation and Research has required electronic submissions in eCTD format since 1 January 2008 and, as part of the most recent version of the Prescription Drug User Fee Act (PDUFA IV), is implementing a single electronic review environment for all FDA Centers by 2013. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EEA) has required eCTD format for Centralised Procedure applications since the beginning of last year.
“The eCTD has become the standard for numerous regulatory agencies around the world,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “Yet, regulatory authorities are reporting serious problems with the quality and consistency of many of the eCTD submissions they are receiving.”
The popular RAPS eCTD training workshops are intensive, hands-on programs designed to help regulatory professionals bolster their ability to create compliant eCTD submissions for FDA and other global regulatory agencies. The impartial workshops are not tied to any specific submissions software platform and focus on illustrating best practices and skills required to successfully produce eCTD submissions. Both workshops will be led by renowned expert faculty Antoinette Azevedo, president, e-SubmissionsSolutions.com.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org