The regulatory environment is constantly shifting and changing. This dynamism necessitates keeping abreast of current information from a variety of sources. 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 regulatory intelligence than keeping up with the latest regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, competitor information are just a few of the valuable sources of information that can help regulatory affairs professionals to develop successful regulatory strategies.
The monitoring and gathering of RI will ultimately culminate in developing a regulatory strategy which can result in decreased time to approval; potentially decreased cost of product development through strategizing risk based on current information; and maximization of target market(s).
In addition, as more companies are conducting trials and filing marketing application worldwide, the need to keep abreast of worldwide regulatory information is increasing in importance as a change in the global landscape can affect the global regulatory strategy. RI allows a regulatory professional to determine requirements for conducting global clinical trials, manufacturing requirements, advise personnel, answer strategic regulatory questions and write or construct a global marketing application.
This class examines the scope of regulatory intelligence which encompasses: Information sources, monitoring the regulatory landscape (periodic versus ongoing), using an RI database and other sources to research the regulatory question, how to summarize, analyze, integrate and present RI, as well as discuss implementation choices-in-house, consultants, information services, or a mixture-and the advantages/disadvantages of each choice.
Hands-on class exercises help participants gain experience using a regulatory intelligence database to search and summarize regulatory intelligence information.
- Discuss what Regulatory Intelligence is and why it is important to companies
- Identify multiple sources of Regulatory Intelligence
- Monitor the constantly changing regulatory landscape
- Break down a regulatory research question in to researchable units, conduct the research using a Regulatory Intelligence database
- Summarize and present Regulatory Intelligence findings back to a team
- Archive and store RI
- Apply and integrate Regulatory Intelligence to current company practices and global regulatory strategy
- This course is designed for seasoned regulatory affairs professionals looking to develop their skill set, as well as other research and development professionals who are interested in learning a new skill
Meredith Brown-Tuttle, R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- What is Regulatory Intelligence(RI), regulatory information and sources of RI
- How RI is conducted at large, medium and small drug, biologic and medical device companies
- How RI differs at each stage of product development
- Using Regulatory consultants to conduct RI and what to expect
- How to break down regulatory research questions down into researchable components
- How to conduct regulatory research using the internet and an RI database
- How to compile, analyze and summarize regulatory information
- Storage and archiving RI
- Use regulatory intelligence databases to answer a series of RI question
- Learn to fill out RI overview form for effective presentation of information to team
Registration 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 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-091-L01-P. Released: 9/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.