Whitsell Innovations (WI), Inc., a full-service medical and scientific writing company headquartered in Chapel Hill, NC, will be one of the exhibitors at Drug Information Association (DIA) 2013 49th Annual Meeting this year. The DIA meeting is scheduled to be held from June 23 through June 27, 2013 in Boston, Massachusetts.
President and founder of WI Robin Whitsell, Operations Manager Connie Morris, Senior CMC Regulatory Consultant Mary Ellis Bogden, and Business Development Associate Natalie Becker will all be in attendance at the Whitsell Innovations, Inc. Booth Number 1815.
The team will be discussing the experience of WI with medical writing and outsourcing best practices for pharmaceutical, biotech and device companies including the documentation required for submissions to the Food and Drug Administration (FDA) and international regulatory bodies during the pre-clinical and clinical development process. They will also address how industry clients use medical writers to share clinical data in manuscripts, training materials, and presentations.
[quotes class=”quoteleft”]“The DIA conference is a great opportunity to interact with industry leadership,” says Ms. Whitsell. “Every year, we attend great workshops, meet with clients and potential clients, and are impressed by the caliber of the educational offerings.” [/quotes]
WI members will also be available to discuss the changing regulations regarding electronic technical document (eCTD) submissions, the trends in the writing of Clinical Study Reports (CSRs), and the approaches to streamlining Periodic Adverse Safety Update Reports (PADERS), and regulatory updates associated with Period Safety Update Reports (PSURs). They will also be available to discuss cGMP regulations and rest of world filings.
DIA is a nonprofit, global, professional association of nearly 18,000 members who work in every facet of the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products. DIA is committed to the broad dissemination of information among its members, with continuously improved professional practice as the goal. DIA serves our members in a neutral, global environment that operates independent of the influence of any one organization or authority.