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.
This 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 other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.
Martha French have over 28 years combined experience in biomedical research and regulatory affairs. As Vice President of Regulatory Affairs at Bellicum Pharmaceuticals she was responsible for the management of all US and European pre-market regulatory activities for novel CAR and TCR T cell therapies that incorporate molecular switches. As Director of Regulatory Affairs at InGeneron Inc., she was responsible for the management of European and US regulatory activities for medical devices that prepare autologous regenerative cell therapies at point of care. At Introgen Therapeutics, Martha led US and European pre-market regulatory activities for three novel biologic products. She was responsible for the filing of the first gene therapy Biologics License Application (BLA) to the FDA and filed two gene therapy Marketing Authorization Applications (MAA) to the EMA. At Valentis, Inc. (formerly Gene Medicine Inc.), Ms. French led the Analytical Sciences core teams in support of the company’s cardiovascular, oncology and PEG protein programs. With long tenure at Lark Technologies, as Vice President of Operations, she managed the DNA sequencing, library screening, restriction enzyme mapping and PCR services. Ms. French graduated from Carroll University with a Bachelor of Science in Biology, taught Regulatory Affairs for the 2008 Human Gene Therapy course at the University of Texas Graduate School of Biomedical Sciences.
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Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
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City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
