BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T070857Z UID:5828c722-8e6b-414f-9b1f-ac627ec8cfb8 DTSTART:20201214T083000 DTEND:20201215T083000 CLASS:PRIVATE DESCRIPTION:
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\n\n*** LIMITED T IME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!
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\n\nThe international agreement to assemble all Quality\ , Safety and Efficacy information for a drug or biologic product into a co mmon 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 .
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\n\nThis two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and ot her documents into the CTD\, using tools for the project management of the CTD preparation\, and pre-publishing an eCTD.
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\nMBA\, RAC\,President &\; CE
O\, Synergy Consulting (Ex-FDA Official)
Peggy J. Berry \, MBA\, RAC\, is the President &\; CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug developm ent. She also provides group and one-on-one training in drug development\, regulatory affairs and project management topics. Prior to founding Syner gy Consulting in 2020\, she was Vice President of Regulatory Affairs at In smed (2/2020-5/2020) where she was responsible for the development and imp lementation of global regulatory strategies and the management and oversig ht of the regulatory affairs department. Prior to Insmed\, she was Vice Pr esident of Regulatory Affairs and Quality at Amarin (3/2009-2/2020). She h as also held a variety of senior level positions at Dyax (5/2006-3/2009)\, MGI Pharma (now Eisai\; 7/2005-5/2006)\, AstraZeneca (10/2001-7/2005)\, a nd Dey Pharma (now Mylan\; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX On cology and Cato Research Ltd\; 1992-1997) and has worked in review divisio ns at the FDA (1985-1992). In addition\, Ms. Berry consults for a number o f companies in the regulatory and quality area\, conducts a number of trai ning courses\, and is active in the Regulatory Affairs Professionals Socie ty. She is the editor of the 2010 book "\;Choosing the Right Regulator y Career"\; (RAPS\, MD) and author of the 2011 book "\;Communicati on &\; Negotiation"\; (RAPS\, MD).
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\n\nPlea se contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:
\n\n- Multiple participant discounts
\n- Price quota
tions or visa invitation letters
\n- Payment by alternate channels (P
ayPal\, check\, Western Union\, wire transfers etc)
\n- Event sponsor
ships
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\nNO REFUNDS ALLOWED ON REGISTRATIONS
\nService fe
es included in this listing.
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