12 August 2009
12:00–1:30 pm ET

The medicinal properties of herbal products, called botanical drugs, are well accepted by populations around the world. However, very few are pursued in the US as prescription drugs. Their complex multi-component formulation and a poor understanding of their mechanism of action pose unique challenges to regulatory reviewers. FDA accepts reduced nonclinical safety and chemistry, manufacturing and controls (CMC) data to support an Investigational New Drug (IND) application for botanicals that have been legally marketed anywhere in the world with no known safety concerns, which can be extrapolated to a future New Drug Application (NDA) for the same product.

This case-based Webcast will discuss the main issues in presenting CMC and previous human exposure data, and establishing clinical efficacy of botanicals so that you will learn to avoid common mistakes and identify possible solutions proactively.

Professional Levels: II, III, IV

Learning Objectives:
Upon completion of this Webcast, participants should be able to:

• Identify key CMC issues related to botanical products
• Understand how to collect and present marketing data in support of INDs and NDAs
• Recognize the importance of discussion with FDA's Botanical Review Team
• List preclinical and clinical requirements for botanical drugs

Who Should Attend:

• Regulatory professionals working in botanical companies that market their products in the US and EU or are considering entering these markets
• Regulatory professionals working for US companies that are considering the purchase of botanical products developed in non-US markets or vice versa
• Regulatory professionals consulting with companies developing botanical products for the US market
• Business professionals looking to understand the risks and benefits of investing in botanical products
• Senior management of botanical companies in India, China, Africa and Latin America considering marketing their products in the US

Speaker(s):

Mukesh Kumar, PhD, RAC, senior director, regulatory affairs, Amarex
Kumar leads the regulatory affairs and quality assurance departments at Amarex, a full-service pharmaceutical product development company based in Germantown, MD. His key expertise is in global regulatory and business processes for medicinal and diagnostic products. Kumar has been involved in about 100 clinical trials in more than 60 countries, has made several hundred US Food and Drug Administration (FDA) submissions, and has arranged a number of meetings with FDA. In addition, he has had made regulatory submissions in the EU and India. Kumar has authored numerous articles in peer-reviewed journals. He is a recognized expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Kumar holds a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston and premier institutions in India. He has earned the RAC credential.

Robert Schiff, PhD, CQA, RAC, CEO, Schiff & Company Inc
Robert Schiff is founder and CEO of Schiff & Company, a regulatory affairs, compliance and clinical research organization. Previously, he worked in industry with Warner Lambert Company, Hoffmann-La Roche, Inc., J.T. Baker Chemical Company (Richardson-Vicks) and the Hyland Division Travenol Laboratories (Baxter). He also was an Assistant Professor in the Department of Anatomy at Tufts University Schools of Medicine and Dental Medicine. Schiff has authored more than 50 publications and holds several patents on medical products. He holds a BS from the City College of New York, MS from Iowa State University, and PhD from the University of California at Davis. Schiff has earned the RAC credential and is a Certified Quality Auditor, and is a member of RAPS' Board of Editors for Regulatory Focus.

Cost: Members: $295 USD; Nonmembers: $395 USD
Cost is per site - unlimited participants