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AAHP Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products: Keeping Your Business Compliant under FDA’s New Proposed Guidance
June 27, 2019 - June 28, 2019
About the Summit
Now more than ever, it is vital to your business to be up to date on compliance issues in every area. To assist the manufacturers and labelers of homeopathic products, the American Association of Homeopathic Pharmacists (AAHP) is offering regulators, quality experts, suppliers and those with allied interests a highly specialized one-day training. The small setting promises interaction with experts and peers to address your business concerns for a fraction of the cost of multiple consultants.
FDA is expected to adopt its guidance of risk-based enforcement. Do your products fall into the regulatory priority categories the agency identified: products with reported safety concerns; ingredients associated with safety concerns; non-oral and non-topical administration; marketed for infants, children, the elderly, etc.; or product not adhering to standards such as the Homoeopathic Pharmacopoeia of the United States.
Don’t miss this powerful one-day investment — especially if your company will be present in the exhibit hall for the Joint American Homeopathic Conference.
Who Should Attend
Recommended attendees are staff with homeopathic manufacturers or businesses and consultants for this pharmaceutical industry related to manufacturing and labeling compliance. Company leaders, such as the President and CEO, are also welcome.
- Quality Assurance
- Quality Control
What You Will Learn
- How hot-button policy issues may impact your company’s bottom line
- How best to prepare for FDA’s new enforcement priorities
- Save time and money developing a compliance strategy at small group workshop with access to in-depth experts to ensure business operations
- Gain insight into important compliance procedures
- Network with the largest gathering of the American homeopathy community at the 14th annual Joint American Homeopathic Conference’s Reception.
AAHP Summit attendees will gain valuable insight on quality, safety and regulatory issues in workshops developed under the guidance three experts. The limited-seating workshops also provide easy access to these notable professions for specific questions during this time of change for the industry.
Quality Track Leader
George Bernstein, PhD
President, MAI Consulting
Dr. Bernstein's expertise ranges from GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with FDA. And for 30 years, his family (including pets) have used homeopathic medicines.
Regulatory Track Leader
Ann M. Begley
Partner, Morgan, Lewis & Bockius LLP
Based in Washington DC, Ann Begley advises clients on FDA and FTC legal and regulatory issues relating to drug, cosmetic, dietary supplement, food, and medical device products — specializing in OTC drugs and clinical research matters. She provides guidance on product approval pathways, formulation, labeling, product advertising, compliance and strategic issues. Ann has represented many clients in connection with FDA and FTC enforcement actions/inquiries, as well as competitor challenges before the Better Business Bureau’s National Advertising Division.
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.
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.
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.
Analytical Methods Development Laboratory Manager, Boiron France
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.
Director of Process Validation, Hyland's
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.
Analytical Method Development, Boiron France
Track 2: Safety
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.
Richard Kingston, PharmD
President, Regulatory and Scientific Affairs, SafetyCall International, PLLC
Industrial and Regulatory 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 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
Matthew D Reed, PhD, DABT, Fellow ATS
Principal, Coelus LLC
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.
Susan J. Hewlings, PhD, RD
Director, Scientific Affairs, Nutrasource
Professor, Central Michigan University
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.
Eric L. Foxman, RPh
Senior Scientist, HPCUS
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.
Mark Land, MS, RAC
VP, Government & Regulatory Affairs, Boiron USA
Registration is separate for the Summit and the Reception.
Opening Reception, June 27th
|Member||Non Member||Member||Non Member|
AAHP Summit, June 28th
|Member||Non Member||Member||Non Member|
Thursday, June 27, 2019
5:00–7:00 p.m. Opening Reception in the Hilton Baltimore Carroll Room, overlooking Camden Yards
Friday, June 28, 2019
|8:00–9:00 a.m.||Registration Open|
Opening Session: Scott Melville, Consumer Health Products Association
Morning Break with JAHC Attendees
|10:15–11:45 a.m.||Establishing Analytical Specification
by Stephanie Chanut
by Richard Kingston, PharmD
SafetyCall International, PLLC
by Susan J. Hewlings PhD, RD
|1:00–2:30 p.m.||Process Validation
by Eric Baier & Karl John Schottig
Hyland's, Inc., a division of Standard Homeopathic Co.
|Methods in Toxicology
by Matthew D. Reed, PhD, DABT, Fellow ATS
|Topics in Labels and Labeling
by Eric L. Foxman, RPh
Afternoon Break with JAHC Attendees
|3:00–4:30 p.m.||Finished Product Testing/Content Uniformity
by Fanny Guillot
|Populations and Routes of Administration||Enforcement Hot Topics
by Mark Land, MS, RAC
|5:00–6:30 p.m.||Joint American Homeopathic Conference Opening Reception (cash bar)|
Click here to make reservations. Use the dedicated link for the discounted conference rate through the Joint American Homeopathic Conference website: https://book.passkey.com/gt/216938400?gtid=1f7bc1cc225e8985a71c7801d8278673
Alternatively, call the hotel directly at 866-238-4218 and reference the Joint American Homeopathic Conference discounted rate.
The group block could sell out prior to the discount cut-off date of Tuesday, June 4, 2019. Booking your reservation early is strongly encouraged.
About Baltimore and the Hotel
For information on the hotel and surrounding area, please visit the website for the Joint American Homeopathic Conference.
The Hilton Baltimore and its prime Inner Harbor location offer many options for breakfast and dinner on your own. Within the hotel there is the Coffee Bean & Tea Leaf café, the Diamond Tavern restaurant, and the lobby bar.
The Emerson Group
The Emerson Group is a consumer products equity organization focused on accelerating mid-market brand growth. It also operates internationally, providing partners in the European, South American and Asian Pacific regions with the expertise and infrastructure necessary to successfully operate in the U.S. market. An Emerson Group division, Emerson Logistics is a consumer products logistics solutions provider. A third division, Emerson Marketing, is an analytics and insights-based consumer products communications organization.
Platinum Level Sponsors
In 1932 in Lyon, France, twin brothers and pharmacists Jean and Henri Boiron set out to develop a way to prepare reliable homeopathic medicines for their patients. Today Boiron continues as an independent pharmaceutical laboratory that prides itself on quality manufacturing and responsible environmental practices. We are passionate about integrating the benefits of homeopathic medicine into daily life.
Founded in 1903 and dedicated to supporting the health and wellness of families, Hyland’s is a leading homeopathic company in North America and a top natural OTC brand. Hyland’s products have been shared by families for generations. Hyland’s medicines are prepared with the highest quality active ingredients and follow strict standards of preparation.
MAI Consulting, Inc.
MAI Consulting Inc. in Chapel Hill, N.C., helps homeopathic manufacturers prevent inspection problems before they arise and address existing compliance issues. As a pharmaceutical consultant, Dr. George Bernstein, PhD, works to improve the efficiency, compliance, and quality of small, medium, and large domestic and global allopathic and homeopathic companies.
Matrixx Initiatives, Inc.
Matrixx Initiatives has been engaged in the development and marketing of better ways to feel better through over-the-counter health care products for over 20 years. Matrixx Initiatives manufactures and markets Zicam® brand homeopathic OTC products, including its clinically proven homeopathic ZICAM Cold Remedy Nasal Spray and Swabs and Cold Remedy RapidMelts®.
Company Description: Nelsons is the UK's leading manufacturer of natural healthcare products, with a long-standing commitment to supplying the highest quality natural healthcare products that meet all regulatory and quality standards. Since 1995, Nelson Bach USA Ltd has been the sole North American distributor of RESCUE REMEDY®, BACH® Original Flower Remedies and SPATONE®.
Similasan is dedicated to helping families feel good about feeling better. Our natural remedies provide temporary symptomatic relief from ailments of the eyes, ears, nose, head, and chest. Originating in Switzerland in 1980, the Similasan brand became popular across Europe. Today, Similasan remedies are widely used and well-respected in North America.
Eric L. Foxman Consulting
Using in-depth expertise from decades of positions within HPCUS and AAAP, Eric Foxman, RPh, offers private consultations to find solutions to our industry’s special compliance challenges. Eric helps companies comply in the areas of labeling design/text, with the HPUS, and cGMP through reviews of literature, protocols, and manufacturing technologies. He is also available to serve as a spokesperson in these areas.
Our staff conceptualizes and facilitates early to late phase development of pharmaceutical intellectual property and provides consulting services in integrated drug development strategies, toxicology, and pharmacology. We specialize in applying our expertise to pharmaceutics, due diligence, pharmaceutical-related government grants and contracts, inhaled drug development, inhalation and general toxicology, and human health hazard assessment.
CPG Linkages, LLC
Connecting senior-level association, manufacturer and retailer executives through targeted 1:1 meetings, annual industry overviews, conferences and other opportunities to drive mutual business growth.