Meet us at DIA RSIDM in North Bethesda, MD on 08th–10th February 2016
MakroCare is participating at DIA Regulatory Submissions, Information, and Document Management Forum on Feb 08 – Feb 10 2016 in Bethesda North Marriott Hotel and Conference Center. Visit us at Booth no 409.
Regulatory, in recent years, is been considered as an end-to-end process as industry as a whole is converging. Document management, publishing, and technical regulatory requirements are all subsets of regulatory information management at its broadest definition. This course of managing documents starts at the creation of that document as part of the clinical trial.
MakroCare has successfully helped many Pharma, Biotech and Device companies right from designing their Regulatory Strategy to getting product approvals globally. Our functional services include Reg Intel, Affiliate support, RIM Operations, CMC Authoring, LCM, Labeling & Submission Management.
EDM, ERS, and RIM have combined for the 2016 Regulatory Submissions, Information, and Document Management Forum. This forum will cover topics in four tracks: Electronic Regulatory Submissions (ERS), Regulatory Information Management (RIM) Business, RIM Technology, and Electronic Document Management (EDM).
This conference serves as a forum for the discussion of emerging operational standards, best practices and the processes for submission, creation, and maximum use of regulatory information. The conference continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards. The RIM business-focused track provides the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact as well as gain a greater understanding of key issues shaping the global regulatory environment. The technology track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned. The traditional ERS and EDM tracks will focus on emerging trends and best practices in regulatory submissions and electronic document management life cycle, respectively.