We are thrilled to offer a first look at the speakers and sessions for our upcoming Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products! This unique one-day workshop is designed to help you manufacture safe products while complying within FDA and FTC guidelines. Some of the workshops included in the Summit are:
Homeopathic Product Substantiation from Concept to Shelf
Susan J. Hewlings PhD, RD, Director of Scientific Affairs for Nutrasource and Professor at Central Michigan University
The Federal Trade Commission (FTC) has taken action against several products after releasing its enforcement policy statement on marketing claims for OTC homeopathic drugs in November 2016. This workshop will address recent concerns from FTC as well as FDA and prepare the industry. Manufacturers and labelers will learn to find: gaps in marketing to fulfill unmet therapeutic needs; competitive positioning; jurisdictions where the data may be used; and regulatory precedence.
Process Validation: What Is It for Homeopathic Products?
Eric Baier, Senior Vice President, Regulatory & Technical Affairs and John Schlottig, Director of Process Validation, both at Hyland’s, Inc./Standard Homeopathic Company
Typical process validation approaches changed with FDA’s 2011 Guidance for Industry: Process Validation: General Principles and Practices. This workshop will highlight the key differences between this guidance and what was previously practiced. After a survey of the requirements, many of the unique challenges and considerations for homeopathic manufacturers will be discussed, including what you must know before you begin to develop a successful process validation program.
Moves Toward FDA Requirements: Establishing Homeopathic Finished Product Specifications and Shelf Life
Fanny Guillot, Regulatory Affairs Officer, AMM (marketing authorization) Development Unit, Boiron (France)
Homeopathic manufacturers and private labelers can use global synergies to demonstrate quality and safety to U.S. health authorities. As U.S. Food and Drug Administration (FDA) prepares to adopt its draft guidance, this workshop will show how the industry could use a multi-country approach to strike a balance between analytical cost and quality assurance.
Enforcement Hot Topics: It’s Not the 483, It’s the Consumer
Mark Land, MS, RAC, President of American Association of Homeopathic Pharmacists and Vice President of Government & Regulatory Affairs, Boiron USA
FDA’s draft guidance is a shift from a compliance policy guide to risk-based enforcement with a list is six areas of priority. This workshop will identify areas in which manufacturers and private labelers can reduce their risk through an analysis of warning letters, import alerts, inspection citations, and recalls.
Topics in Labels and Labeling
Eric L. Foxman, RPh, Regulatory Consultant, Secretary for American Association of Homeopathic Pharmacists, and Senior Scientist for Homeopathic Pharmacopeia Convention of the United States
FDA’s draft guidance states the agency’s enforcement actions will focus on various types of products, including those associated with potentially significant safety concerns; those intended for the prevention or treatment of serious and/or life-threatening diseases and conditions; and those intended for vulnerable populations. This workshop will examine how FDA’s enforcement focus categories affect homeopathic product labeling and provide examples to help companies minimize risk.
Analytical Development Challenges in Homeopathy: To Identify and to Quantify Quality, and Toxicological Markers
Stéphanie Chanut, Pharmaceutical Development Laboratory Manager, Boiron (France)
The most frequently cited GMP deficiency during homeopathic facility inspections in 2018 was 21 CFR 211.160(b): “lack of scientifically sound laboratory controls.” This workshop will review research of various analytical methods applied to homeopathic active ingredients and dosage forms.