UNDERSTANDING THE DRUG DEVELOPMENT/REVIEW PROCESS (1/2 Day)

UPCOMING DATES:

Course Description:

Designed for life sciences professionals from all disciplines who require (or desire) a basic understanding of drug development from both an FDA and industry insider perspective.Utilizes a ‘backward planning’ perspective – focusing on drug development with maximum patient benefit and commercialization in mind.

Targeted for numerous life science disciplines, including:

Clinical
Regulatory
Commercial
Medical
Legal
Compliance
Training
Medical writers
Communications

Topics include, but are not limited to:

Drug Development phases and definition
IND and NDA (BLA)
FDA organizational structure – Centers, Offices, Divisions, etc
Working with FDA (meetings, preparation and follow-up, expectations, interpersonal interactions)
FDA internal interactions
FDA external interactions: other regulatory agencies, advisory committees, etc.
FDA Reviewer backgrounds and roles
PDUFA, FDAAA and other laws and their regulations
The importance of FDA Guidances to successful drug development
Utilizing the Targeted Product Profile to ensure maximal patient benefit, labeling, and commercialization.
Understanding review times and special review - implications and use (breakthrough, expedited, 505b2, accelerated approval – subpart H and E, fast track, etc.)
Action letters and responses – what do they mean?
Best practices of working with FDA during the drug development process
Understanding FDA’s thinking on substantial evidence standard vs. “emerging” categories of evidence like RWE and meta-analyses

Participants may NOT receive a refund for any reason (unless LRA cancels course). If the participant cannot attend the course they may send a substitute. Course registration may be transferred to another participant at any time by notifying lucyrose01@aol.com prior to the start of the course.

Price: $750.00

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To register, please fully complete the registration form below, including checking the box agreeing to the terms, then click submit.

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Terms & Agreement:*

This program and all materials supporting the program are intended for educational purposes only. They are not intended to provide legal, regulatory or risk advice or guidance regarding any specific situation or scenario and are not a substitute for the advice of your advisors on specific issues. This material is based on the laws and regulations and DDMAC/OPDP/APLB enforcement letters in place at the time of the presentation and reflects the individual opinions of Lucy Rose and Associates, LLC. Because regulations change and risk evaluation is a subjective matter, the information and opinions provided and expressed as part of the program should not be relied upon for decision-making purposes. Further, Lucy Rose and Associates, LLC does not warrant or guarantee that you or your employer or any of its employees or contractors, by relying on the educational materials provided by the program, would not be subject to regulatory or legal enforcement actions. This material is copyrighted ; it or any part of it may not be photocopied, reproduced, disseminated ,or otherwise used by anyone other than Lucy Rose and Associates, LLC without the express written prior authorization of Lucy Rose and Associates, LLC.

Each individual paid registration is for one attendee. The program may not be shared with anyone other than a paid registrant either during its live presentation or in any recorded format.

The program or any part of it may not be recorded or reproduced in any format including but not limited to: video, photographs, screen shots, audio recordings or by any other mechanism in existence now or in the future capable of reproducing or transmitting the program in whole or in part.

Copyright 2020 by Lucy Rose and Associates, LLC. All rights reserved.

I have read and agree to the terms above.