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CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 20-21, 2014
Who Should Attend
This course is intended for Professionals in the Pharmaceutical, Biotech and related fields who are responsible for compilation and submission of electronic applications to FDA. It will be especially valuable to:
• Regulatory Affairs Professionals
• Documentation Specialists
• Managers and Supervisors
• Professionals managing clinical data Description
Electronic Submission is an extremely efficient tool for managing submissions of complex technical documentation to regulatory authorities involved in the drug approval process. The use of electronic submissions allows for effective life cycle management of series of documents that are submitted to the FDA during their review process. The electronic submission process also provides an user friendly document for the FDA reviewers. All required information is readily available for the FDA’s review process. Upon completion of this course, you will be a master at compiling and submitting complex technical applications through FDA’s electronic gateway.
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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Candis B. Edwards; Senior Vice President Clinical Regulatory Affairs, Amneal Pharmaceuticals
Candis B. Edwards, Senior Vice President, Clinical Regulatory Affairs at Amneal Pharmaceuticals, LLC, has over thirty-five years of experience in Regulatory Affairs, Clinical Affairs, Product Research and Development, Project Management, Quality Assurance, cGMP Compliance and Quality Control.
She currently holds an Associate Professor position at St. Johns University, where she provides instruction on the FDA regulatory approval process in the graduate program in the Department of Pharmaceutical Sciences at the College of Pharmacy and Health Sciences.
Ms. Edwards is also the founder and CEO of Generic Solutions, Inc. a pharmaceutical consulting firm that specializes in regulatory support and solutions for FDA filings, including INDs, NDAs, ANDAs and DMFs, in eCTD format. The firm also provides product specific cGMP facility inspection support for product approvals and services non competing organizations.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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