FDAnews Announces Best Practices for Managing Clinical Trial Materials, Webinar, Jan. 30, 2014

With the high cost and strict handling requirements for products entering clinical development, the logistics of clinical trial supplies are clearly more critical than ever. The Best Practices for Managing Clinical Trial Materials webinar will help trial sponsors see that an effective materials process, based on effective and sound principles, can become the foundation for a successful trial.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) January 22, 2014

Best Practices for Managing Clinical Trial Materials
**FDAnews Webinar**
Jan. 30, 2014 — 12:00 p.m. – 1:30 p.m. EST
http://www.fdanews.com/ManagingCTMaterials

With clinical trial sites increasingly scattered around the globe, supply planning and distribution can make or break a study.

Investigational products must be manufactured, stored and distributed in strict accordance with Good Manufacturing Practices, utilizing labeling and packaging that match the trial protocol.

But only effective master planning can ensure that deliveries of those products will not be not delayed at the risk of the inventory expiring.

Sponsors are well aware of the examples of catastrophic failures in managing clinical trial materials. A 2010 earthquake in Chile destroyed thousands of frozen samples for clinical trials … Hurricane Katrina destroyed virtually all clinical trial materials at Tulane and Louisiana State University in 2005 … floods in Iowa in 2008 wiped out more than $200,000 worth of clinical trial facilities and materials.

But skipping even the simplest day-to-day best practices can derail a trial, such as overlooking expiry dates on existing stock, storing materials at improper temperatures in customs warehouses, and making last-minute deliveries to the wrong address.

Today, sponsors simply cannot afford such errors. In this webinar, a leading clinical trial materials and supply chain expert will provide proven best practices to improve your company's forecasting of clinical trial materials needs, teach you what FDA and international regulatory authorities require and provide tips for managing catastrophes.

Attendees to this webinar will learn:

  •     How to develop a robust, compliant supply based on proven master planning that focuses on dependent and independent demand forecasting.
  •     The secrets to leveraging master planning to control key planning stage elements: Patient recruitment, expiration dating of supply and integration across all manufacturing steps. Metrics will be identified and explained that will help you create an accurate Demand Calculation program to ensure enough product is developed and shipped at the right times.
  •     Ways to identify the most serious production threats to a strong materials program, including shortening of expiration dates due to lack of long-term stability data, the necessity to package small product lots with placebos in the same packaging, and the need to package and track small product lots.
  •     How master planning will make it possible to generate and control accurate records and master files.
  •     Tips for handling catastrophic events.
  •     The latest FDA and EU materials requirements — and proven compliance tools.

With the high cost and strict handling requirements for products entering clinical development, the logistics of clinical trial supplies are clearly more critical than ever. Firms conducting or relying on clinical trials have begun to realize that an effective materials process, based on effective processes and sound principles, are the foundation of a successful trial.

Best Practices for Managing Clinical Trial Materials will help sponsors see that an effective materials process, based on effective and sound principles, can become the foundation for a successful trial.Sign up today.

Meet Your Presenter
Hedley Rees is a member of the Steering Committee of the Advanced Manufacturing Supply Chain Initiative at Oxford BioMedica. Currently the Managing Consultant at Pharma Flow specializing in international supply and trial issues, Rees has also held senior positions at Bayer UK, British Biotech, Vernalis, Ortho-Clinical Diagnostics, and OSI Pharmaceuticals. Rees is the author of the acclaimed book "Supply Chain Management in the Drug Industry."

Who Will Benefit

  •     Drug manufacturers
  •     Biologics manufacturers
  •     Combination products manufacturers
  •     CROs
  •     Clinical trial sites
  •     Distribution vendors

Conference Details
Best Practices for Managing Clinical Trial Materials
**FDAnews Webinar**
Jan. 30, 2014 — 12:00 p.m. – 1:30 p.m. EST
http://www.fdanews.com/ManagingCTMaterials

Tuition
$547 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register
Online:     http://www.fdanews.com/ManagingCTMaterials
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.