Training Course:Clinical ProtocolsSchool/Trainer:The Center for Professional Advancement
New Brunswick, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' Achieving a successful clinical program is based on collecting and evaluating precise safety and efficacy data that will form the basis of information for product approvals by global regulatory agencies.
Clinical protocol development is key for product approvals that come under the jurisdiction of INDs, NDAs, BLAs, ANDAs, and CTDs. The clinical process necessary to write protocols that will meet new product development will be presented along with detailed discussions of protocol requirements for phases 1, 2, 3, 3b, and 4. Specific components in protocol content will be detailed especially for inclusion and exclusion criteria, valuations of safety and efficacy, and specific requirements for reporting AEs and ADRs via FDA regulations and EU Directives. Case Report Form (CRF) development and content will be presented.
Discussions include regulatory components and sponsor and investigator obligations in implementing clinical protocols. The significance of investigator meetings, clinical site selections, pre-investigator site visits (PISVs) and international research programs, and a protocol workshop.
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Please go to the school's official website for training price and schedule:
http://www.cfpa.com
Phone:(732)238-1600
School Address:
Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com
Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com
Jobs & Resumes: New Brunswick
Houses & Roommates: New Brunswick
Other training courses offered by The Center for Professional Advancement:
ICH Q10: Pharmaceutical Quality System
Current Good Manufacturing Practice (cGMP) for Purchasing
Excipient GMPs
Sulfonation and Sulfation
Pharmaceutical Process Development
Skin Product Development
Laboratory Control Systems
Pharmaceutical cGMPs and FDA Inspections
Cosmetic Product Formulation
Regulatory Compliance for the Personal Care Products Industry
Hair Product Development
Preparing for and Surviving an FDA Inspection
cGMP Auditing - Strategies for Compliance
Patent Law
INDs, NDAs vs CTDs Global Regulations
Granulation, Tabletting and Capsule Technology
System Validation, GAMP Harmonization and P.A.T
Lyophilization Technology
Pharmaceutical Quality Assurance and Control
Notice: The course description on this page was captured from the Internet as historical reference or submitted by visitors. It was archived statically and not updated from day to day.
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