course provides a comprehensive approach to the preparation and submission of
documents to the FDA for approval of drug products. Participants receive a
foundation of knowledge about the drug approval process, submission
preparation, and the underlying scientific and regulatory principles involved.
Guidelines for each aspect of research are provided, as well as information on
the structuring and assembly of INDs, NDAs, and post-approval documents.
Information on maintaining on-going relationships with the FDA is also
discussed. The course enables regulatory affairs professionals to prepare
concise documents, provide the FDA with necessary information, and obtain rapid
- Navigate the FDA drug approval system
- Prepare an IND
- Prepare an NDA
- Navigate the FDA review process
- This course is intended for Regulatory, Clinical,
Manufacturing, Technical, and Quality Personnel who require an in-depth
understanding of the drug approval system. The course will also benefit
management, legal, and other personnel who must be familiar with the
essentials of the drug approval system and the preparation and submission
of related documents.
Caroline Ritchie, Ph.D., M.B.A.
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- General Perspective: History; law; definitions; overview of FDA;
establishment registration; product listing; regulatory strategy
- IND Process: FDA IND Form 1571; cover letter; table of contents;
introduction; investigational plan; chemistry, manufacturing, and control;
nonclinical studies (pharmacology and toxicology); clinical studies;
investigator brochure; labeling; USAN procedures; compiling IND; IND
filing; IND review process; amendments to IND; safety reports; annual
reports; IND withdrawal; IND termination
Two: 8:30 a.m. – 5:00 p.m.
- NDA Process: FDA NDA Form 356(h); cover letter; index; labeling;
summary; chemistry section (chemistry, manufacturing, and controls
information; samples; methods validation package); nonclinical pharmacology
and toxicology section; human pharmacokinetics and bioavailability
section; clinical data section; safety update report; statistical section;
case report tabulations; case report forms; patent information on any
patent which claims the drug; patent certification; establishment
description; debarment certification; field copy certification; user fee
cover sheet; compiling NDA; NDA amendments; NDA review process; post-approval
- Exploratory IND: Clinical information; CMC information; safety program
designs; GLP compliance
- Clinical Trials: Phase 0 studies; Phase 1 studies; Phase 2 studies; Phase
3 studies; Phase 4 studies
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-16-033-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1