Regulatory Intelligence 101: What, Where, Why and How to Present Back to the Team

When:  Aug 29, 2018 from 12:00 PM to 4:30 PM

29 August 2018
12:00 – 4:30 pm EDT

Registration Information

RAPS Members: $ 525
Nonmembers: $ 625

Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc.  There is more to RI than the black and white of regulations or guidance documents; there are many colors of possible interpretations found through researching regulatory precedents, industry practices, Health Authority (HA) opinions, competitor information, etc.  HA are dynamic which necessitates the RI Analyst to continuously monitoring the regulatory landscape to keep abreast of current information or possibly changes in information or policy, on a global scale, to develop and maintain successful regulatory strategies.

This program examines the scope of RI including: information sources, monitoring the regulatory landscape, transforming information into actionable intelligence, policy, and how device information differs.

Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

 

Learning Objectives

Upon the webcast's conclusion, you will be able to: 

  • Know what RI is and why it is important to companies
  • Reference a large variety of information sources available (Drug and Device)
  • Monitor the constantly changing regulatory landscape
  • Transform information into intelligence
  • Understand Regulatory Policy and how to influence it

Who should attend

  • Regulatory Professionals at all stages of their career
  • Clinical Research Associates
  • Quality personnel

Speakers

Meredith Brown-Tuttle, RAC, FRAP, President/Principal Consultant, Regulatorium

Meredith has 25 years of industry experience from bench to clinic to approval of both drugs and devices. Meredith is the founder and principal of Regulatorium, a full service regulatory consulting agency, and served as Vice President, Regulatory & Quality at Lyric Pharmaceuticals, Director of Regulatory Affairs at Intermune, APT Therapeutics and Clinimetrics. Meredith has written, managed and led over 30 successful domestic and international IND and NDA submissions. She is a founding instructor at UC Santa Cruz Regulatory Certificate Program and author of two books: “IND Submissions: A Primer” and “Regulatory Intelligence 101.” Meredith graduated with a BA in biological psychology (neuroscience) from San Jose State University.

Additional speakers to be announced soon