Conducting early clinical trials is a means for establishing the initial safety of a drug. Since these clinical trials are only a sample of the larger, actual trial, these studies generally consist of a small number of healthy subjects, on whom lower doses of the drug product are administered. This means that early clinical trials need only small amounts of investigational material.
The FDA, to help such companies from incurring higher costs, as also to reduce regulatory burden during these early stages, has established guidelines to allow early stage investigational products to be manufactured under what may be considered simulated conditions, i.e., those that require less stringent GMPs.
Understanding the way this system, called Phase I GMPS, is very important, as it sets the path for the fuller development of the drug. A four-hour workshop from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, which is being organized on March 26, will give a thorough understanding of Phase I GMPS.
Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar. Please visit globalcompliancepanel to register for this valuable session and gain full understanding of Phase I GMPS.
The aim of this four-hour webinar is to offer a detailed review of everything relating to early stage manufacturing and GMPS, such as the current regulations and guidance documents. Peggy will also review and explain regulatory strategies and logistical considerations for early development stage products. Core considerations of this aspect of early stage manufacturing and Phase I GMPS include vendor selection and management, stability, labeling, and documentation requirements.
Directors, Managers, as well as supervisors in Regulatory Affairs, manufacturing, Quality Assurance and clinical operations, the primary segment that is expected to benefit from this webinar, will get a complete grasp of the differences between GMP requirements for early and later stage clinical development. The expert at this webinar will help them to explore and discuss ways of developing and implementing strategies for early GMPs for Phase I clinical studies.
About the Expert:
Peggy J. Berry is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She is the editor of the 2010 book, “Choosing the Right Regulatory Career” and author of the 2011 book, “Communication & Negotiation”. She consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.