This course is designed for pharmaceutical and biotech professionals responsible for regulatory strategy and operations. It will teach the essentials of regulatory project management, with a focus on how these skills can be applied in the process of creating an initial Investigational New Drug (IND) application. Through the use of lectures, discussions and case studies, participants will learn about the key elements of the regulatory process in the United States, discuss the required elements of an IND, the utility of the Clinical Trials Directive (CTD) for building a foundation for continued development and other key topics.

Who will benefit:
This course will be beneficial to those new to regulatory affairs as well as those with regulatory experience but limited exposure to the early phases of development stage work in the pharmaceutical and biotech industries. Managers who are not versed in regulatory, but are involved with clinical trial programs will also benefit.

Key topics:
* What is an IND?
* The Pre-IND Meeting - Dos and Don'ts
* What is FDA looking for in the initial application
* Is the CTD an option?
* Timeline management
* Submission and post submission success

Learning Outcomes:
* Understanding of the IND process and key decision points
* Understanding of how regulatory strategy drives decisions in the drug development process
* Recognition of regulatory hurdles
* Knowledge of how to build effective submissions
* Recognition of the need to effectively manage expectations and timelines

For all public and customized training offered by HALLORAN, please visit:
http://www.hallorancg.com/training/index.php

Event Website : REGULATORY BASICS by HALLORAN Consulting Group

Location:	Metro Meeting Center, 101 Federal Street, 4th Floor, Boston, MA 02110
Contact:	Margaret Sullivan msullivan@hallorancg.com 781-209-5440
Organization:	Halloran Consulting Group, Inc.
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