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10015 Clinical Development of Stem Cell Therapies: Scientific, Regulatory and Ethical Considerations
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Title:
Clinical Development of Stem Cell Therapies: Scientific, Regulatory and Ethical Considerations
Date(s) And Time(s):
Apr 12 2010 8:00AM - Apr 13 2010 1:00PM
Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
Interest Area(s):
CMC,Clinical Safety/Pharmacovigilance,Clinical Research,Nonclinical,Research & Development
Overview:
Strategies for Enabling the Clinical Development of Stem Cell Products.
Join representatives from academia, industry and regulatory agencies, to analyze the transitional process from discovery and regulatory approval to the therapeutic use of stem cell products. Experts will present specific examples of, and solutions for, issues related to the preclinical, CMC, and clinical stages of development for stem cell products
Featured Topics
• FDA and EMEA experiences with clinical development of stem cells
• CMC: Addressing the issues of reagents, devices and potency
• Preclinical and clinical issues in the development of stem cells for therapeutic use
• NIH Guidelines
• Examples of ASC, ESC and iPC cells in preclinical/clinical development
• Immunosuppression strategies
Learning Objectives:
At the conclusion of this conference, participants should be able to:
• Discuss US and EU regulatory requirements for stem cell products
• Outline strategies for clinical development of stem cell products
• Describe the ethical challenges surrounding stem cell research
• Compare successful product development strategies from industry case studies
• Explain CMC challenges of reagents, devices and potency
Target Audience:
Professionals involved in the development and regulation of stem cells for therapeutic use, including those involved in:
• Biotechnology
• Clinical research and development
• Clinical safety/Pharmacoepidemiology/Pharmacovigilance
• Chemistry, Manufacturing and Controls (CMC)
• • Devices
• • Nonclinical safety and efficacy/Toxicology
• • Quality control/assurance
• • Regulatory affairs/Policy/Drug or device approval/GRP
• • Research and development/Strategic issues
• • Preclinical studies
• • Clinical trials
Event Code:
10015
Contact Information:
EVENT INFORMATION
Contact Marjorie Davis, Program Developer, Phone +1.215.442.6176
Fax +1.215.442.6199, email Marjorie.Davis@diahome.org
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
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10015
Clinical Development of Stem Cell Therapies:
Scientific, Regulatory and Ethical Considerations
(Tabletop)
Fee:
Tabletop…………………$1,500.00
Tabletop Rental Fee includes:
• One (1) 6' skirted table;
• One (1) chair;
• Standard electricity
Each Tabletop rental requires at least one registered attendee to staff the table. All tabletop staff is required to register as an attendee for the conference.
Exhibits Show Dates:
April 12-13, 2010
Bethesda North Marriott Hotel & Conference Center
North Bethesda, MD, USA
DIA Exhibits Contact Information:
Jeff Korn
Exhibits Associate
+1-215-442-6184
Jeff.Korn@diahome.org
Useful Links:
~ Application for Tabletop Display
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TRAVEL AND HOTEL The most convenient airport is Dulles International Airport (IAD) and attendees should make airline reservations as early as possible. The Bethesda North Marriott Hotel and Conference Center is holding a block of rooms at the reduced rate below until March 15, 2010, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
Single $174 Double $174
Attendees must make their own hotel reservations. Contact the Bethesda North Marriott Hotel and Conference Center by telephone at +1.301.822.9200 or and mention the DIA event. The hotel is located at 5701 Marinelli Road, North Bethesda, MD 20852, USA.
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Meeting
| Member Standard | $1105.00 | | NonMember Standard | $1245.00 | | Member Academia | $665.00 | | NonMember Academia | $805.00 | | Member Government | $495.00 | | NonMember Government | $635.00 |
Group Discounts:
GROUP DISCOUNTS: Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
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