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 - June 28
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.
Quality Track Leader
George Bernstein, PhD
President, MAI Consulting
AAHP’s three quality sessions will be shaped by Bernstein’s 30+ years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management.
Bio: A longtime proponent of homeopathy, Dr. Bernstein has more than 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, he has consulted internationally with major pharmaceutical companies (both allopathic and homeopathic) and has lectured on quality systems and root-cause analysis to industry trade groups, quality organizations, and at Interphex. He holds a Ph.D. in Chemical Engineering.
Homeopathic Product Substantiation—Concept to Shelf
Susan J. Hewlings, PhD, RD
Director, Scientific Affairs, Nutrasource
Professor, Central Michigan University
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.
Topics in Labels and Labeling
Eric L. Foxman, RPh
Senior Scientist, HPCUS
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.
Enforcement Hot Topics
Mark Land, MS, RAC
VP, Government & Regulatory Affairs, Boiron USA
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.
Recently Announced Speakers
Establishing Analytical Specifications
Analytical Methods Development Laboratory Manager, Boiron France
Senior Vice President Quality, Hyland's
Director of Process Validation, Hlyland's
Finished Product Testing / Content Uniformity
Analytical Method Development, Boiron France
Methods in Toxicology
Matthew D Reed, PhD, DABT, Fellow ATS
Principal, Coelus LLC
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
7:00–9:00 p.m. Opening Reception (location TBA)
Friday, June 28, 2019
Morning Break with JAHC Attendees
|9:45–11:15||Establishing Analytical Specification||Pharmacovigilance||Claims Substantiation|
|12:45–2:30||Process Validation||Methods in Toxicology||Topics in Labels and Labeling|
Afternoon Break with JAHC Attendees
|3:00–4:30||Finished Product Testing/Content Uniformity||Populations and Routes of Administration||Enforcement Hot Topics|
|5:00–6:30||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.