CenterWatch Announces -- Developing Pharmaceutical Investigational Brochures & Annual Reports: Secrets to Practical Success and Total Compliance Webinar, Jan. 29, 2019

FALLS CHURCH, Va., January 18, 2019 /PRNewswire-PRWeb/ -- Developing Pharmaceutical Investigational Brochures & Annual Reports:
Secrets to Practical Success and Total Compliance
**A CenterWatch Webinar**
Tuesday, Jan. 29, 2019, 1:30 p.m. - 3:00 p.m. ET
https://store.centerwatch.com/p-543-developing-pharmaceutical-investigational-brochures-annual-reports-secrets-to-practical-success-and-total-compliance.aspx

Are accurate data, frequency, methods of administration and safety monitoring procedures included in the IB's?

Do the IB's provide investigators with a clear-cut understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial to prevent patient litigation?

Is the IB updated with the latest information on trials in a timely manner to comply with IRB guidelines? Remember, it's the responsibility of the sponsor to keep the information in the IB up to date, including when the drug has received marketing approval and can be prescribed for use commercially.

In the annual report, is the complete description of any significant Phase 1 protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment provided?

Tiffany Guckin, associate director of regulatory affairs, Invicro, will discuss the importance of both FDA IND annual reports and investigator brochures and the benefits of timely submissions and reviews as well as the content and structure. Over the course of 90-minutes she'll help attendees understand:

•     Essential content to be included in an annual report as outlined in 21CFR312.33
•     The importance of annual reports to the FDA and Sponsors as well as how to develop a world-class annual report compliant with federal regulations
•     Structure and content of an IB per ICH E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)
•     The significance of IBs to research staff and investigators
•     How to ensure that accurate representation of investigations to potential subjects
•     Highlight timely submissions and reviews of both annual reports and IBs, including deadlines for filing of documents in order to maintain compliance
•     Best practices that can be included in SOPs or other regulatory processes, including the nuances included in the working instruction documents

This presentation will highlight appropriate content to be included in annual reports and investigational brochures.

Meet Your Presenter
Tiffany Guckin, MS is the associate director of regulatory affairs; Invicro, a Konica Minolta company. She is a graduate from the University of Connecticut and Quinnipiac University. Tiffany is an experienced regulatory professional with more than 8 years in leading all regulatory operation aspects of IND filings and maintenance, as well as authoring Investigational Brochures (IBs) for early phase imaging research studies.    

Who Will Benefit

•     Clinical research associates
•     Investigators
•     Clinical project managers
•     Regulatory affairs personnel
•     Medical writers
•     Sponsors

Webinar Details:
Developing Pharmaceutical Investigational Brochures & Annual Reports:
Secrets to Practical Success and Total Compliance
**A CenterWatch Webinar**
Tuesday, Jan. 29, 2019, 1:30 p.m. - 3:00 p.m. ET
https://store.centerwatch.com/p-543-developing-pharmaceutical-investigational-brochures-annual-reports-secrets-to-practical-success-and-total-compliance.aspx

Tuition:
$287 per site

Easy Ways to Register:
Online: https://store.centerwatch.com/p-543-developing-pharmaceutical-investigational-brochures-annual-reports-secrets-to-practical-success-and-total-compliance.aspx
By phone: 866-219-3440

About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

SOURCE CenterWatch