Regulatory Department is the key contact with regulatory agencies. Regulatory
must prepare documents that inform the Agency about the proposed development
plan, keep the Agency up-to-date and answer any questions the Agency has about
an on-going investigation, request and prepare for meetings with the Agency to
discuss development plans, construct and write the marketing application and
submit any updates to the marketing application in a concise and informative
Submissions to a
regulatory agency involve more than just writing. They also encompass strategy,
editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on
exercises, new and experienced regulatory professionals learn how to work with
the regulations, guidance documents and style guides to produce submissions
that comply with the requirements and are clear to the reviewers.
In this practical course,
approved drug labels and summary basis of approvals are used to help students
acquire the knowledge and insight needed to understand and begin to construct
core U.S. drug and biologics submissions, including pre-marketing (IND), and
marketing (NDA/CTD) applications.
Participants also gain experience with tools that help manage timelines
and sections needed from contributors.
- Identify the required regulations and guidance
documents for drug and biologic submissions
- Use regulations and guidance
documents to outline and construct a variety of drug and biologic
- Formulate a working knowledge of
regulatory submissions, publishing, and style guides
- Create checklists that encompass
timelines and sections needed from contributors
- Any part of the drug development team who wishes
to know more about the IND submission and amendment process such as:
regulatory associates, quality assurance, manufacturing, clinical, project
management, and pre-clinical personnel will benefit from this course
The course will be led by one of the following
Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.
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Day One: 8:30 a.m. – 5:00 p.m.
- FDA Division Information: Submission Basics; Outlining the submission,
creating the Table of Contents, timing of submission/timelines,
contributions from other departments, editing, style guides, templates,
supportive documents, QAing the submission
- Publishing the Submission: Submission publishing basics; Copies (how many to make
and keep); Introduction to electronic publishing requirements
- Tracking the Submissions: Creating the index history; Creating an issues log
Two: 8:30 a.m. – 5:00 p.m.
- Common Technical Document Format Regular Copy
- Pre-Market: FDA Meetings (Type A, B and C): Pre-IND, Phase I, Phase
II, End of Phase II, requesting the meeting, preparing the meeting
package, meeting minutes; The IND Submission; Routine IND Submissions: Clinical,
Non-Clinical, CMC, Annual Reports, Investigator Brochure updates, protocol
/protocol amendments, Investigators; Additional IND submissions: Fast
track, orphan drug, special protocol assessment
- Marketing Application: NDA in a CTD Format
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.
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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#: 0778-0000-17-009-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1