Inaugural Industry Reception - Thursday, June 27th

Where: Hilton Baltimore Carroll Room overlooking Camden Yards

AAHP’s special evening reception celebrates its inaugural Summit. Join us for remarks from thought leaders and networking with senior executives from the homeopathic industry and other special guests. Hors d’oeuvres and cocktails will be served. Business attire is encouraged.

Speakers
Scott Emerson
Founder & CEO, The Emerson Group

Mr. Emerson's forward-thinking consumer products equity organization manages CPG brands in excess of $4 billion, and holds equity positions with small and medium-size brands. It provides international partners with the expertise and infrastructure to successfully penetrate the U.S. market. Mr. Emerson has more than 30 years’ experience, including with Johnson & Johnson, Unilever and Novartis Consumer Health. He has held senior management positions in Fortune 500 companies within brand management, new business development, sales operations and field sales.

 

Workshop Speakers - Friday, June 28th

Review the three tracks below, followed by a detailed schedule.

Opening Keynote

Presented by:
Francis Godwin, MBA
Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

After receiving his undergraduate degree from MIT in Chemical Engineering in 2001, Godwin worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.

Track 1: Quality

Establishing Analytical Specifications

This workshop will propose a development methodology to identify and quantify (if possible) quality and toxicological markers in the tincture and then in the dilutions and the finished products with examples of a gel and a syrup.

Presented by:
Stephanie Chanut
Analytical Methods Development Laboratory Manager, Boiron France

See Workshop Summary

Process Validation

This workshop will highlight the key differences between the FDA’s 2011 Guidance for Industry: Process Validation: General Principles and Practices 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.

 

Co-presented by:
Eric Baier
Senior Vice President Quality, Hyland's  and

John Schottig
Director of Process Validation, Hyland's

See Workshop Summary

Finished Product Testing / Content Uniformity

As 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 the analytical cost and quality assurance.

Presented by:
Fanny Guillot
Analytical Method Development, Boiron France

See Workshop Summary

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Track 2: Safety 

Pharmacovigilance

This presentation reviews best practice post market surveillance at a corporate level, and how implementation can aid in the detection, management, and mitigation of the most serious product safety threats a company may face.

Presented by:
Richard Kingston, PharmD
President, Regulatory and Scientific Affairs, SafetyCall International, PLLC

See Workshop Summary

 

Industrial and Regulatory Toxicology

Part I: Principles of Toxicology

The scientific community, industry, and regulators apply toxicology concepts to safety assessments of new products for human use and to industrial and environmental chemicals and mixtures that are/may become a part of our work force or daily environments. The FDA, EPA, and the international community have set precedents for methods of determining safe human exposure and dose levels.

Part 1: See Workshop Summary

Part II: Application of General Toxicology Studies to Support Regulatory Requirements

Building upon the previous Safety Workshop, Dr. Reed will detail how toxicology is utilized to determine safe starting doses for human use comparing and contrasting pharmaceutical and homeopathic approaches

Presented by:
Matthew D Reed, PhD, DABT, Fellow ATS
Principal, Coelus LLC

Part 2: See Workshop Summary

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Track 3: Regulatory

Homeopathic Product Substantiation—Concept to Shelf

Learn how to develop a substantiation file; what types of claims can you make; and how to navigate the regulatory environment while still providing true homeopathic products.

Presented by:
Susan J. Hewlings, PhD, RD
Director, Scientific Affairs, Nutrasource
Professor, Central Michigan University

See Workshop Summary

Topics in Labels and Labeling

How will FDA’s new guidance affect homeopathic product labeling? Examples will be reviewed to help companies avoid areas of concern, as well as reviewing crucial regulatory labeling requirements.

Presented by:
Eric L. Foxman, RPh
Regulatory Consultant
Secretary, AAHP
Senior Scientist, HPCUS

See Workshop Summary

Enforcement Hot Topics

Prepare for your next FDA inspection. Hear trends detected through an analysis of domestic and international FDA reports. Learn to navigate FDA’s inspection database and dashboard for hot topics.

Presented by:
Mark Land, MS, RAC
VP, Government & Regulatory Affairs, Boiron USA
President, AAHP

See Workshop Summary