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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 - June 28

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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 Staff

Event sponsor

  • Quality Assurance
  • Quality Control

Safety Staff

  • Pharmacovigilance
  • Medical
  • Toxicologists

Regulatory Staff

  • Legal
  • Marketing

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.

Knowledge Leaders

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
Regulatory Consultant
Secretary, AAHP
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
President, AAHP

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 

QUALITY TRACK

Establishing Analytical Specifications

Stephanie Chanut 

Analytical Methods Development Laboratory Manager, Boiron France

Process Validation

Eric Baier

Senior Vice President Quality, Hyland's

John Schottig

Director of Process Validation, Hlyland's

Finished Product Testing / Content Uniformity

Fanny Guillot

Analytical Method Development, Boiron France

SAFETY TRACK

Methods in Toxicology

Matthew D Reed, PhD, DABT, Fellow ATS

Principal, Coelus LLC

Registration

Registration is separate for the Summit and the Reception.

Click Here to Register for the Reception!

Click Here to Register for the Summit!

Opening Reception, June 27th

Team Rates

Early Registration

Full Registration

Member Non Member Member Non Member
1st Attendee $250 $395 $295 $500
2nd Attendee $200 $295 $250 $395
3rd Attendee $175 $250 $200 $295

 

AAHP Summit, June 28th

Team Rates

Early Registration

Full Registration

Member Non Member Member Non Member
1st Attendee $1000 $1,300 $1,200 $1,500
2nd Attendee $900 $1,100 $1,000 $1,300
3rd Attendee $800 $1,000 $900 $1,100
Academic Rate $595
Government Rate $695

Preliminary Schedule

Thursday, June 27, 2019

7:00–9:00 p.m.   Opening Reception (location TBA)

 

Friday, June 28, 2019


8:30–9:30


Opening Session


9:30–9:45



Morning Break with JAHC Attendees



Quality Track



Safety Track



Regulatory Track


9:45–11:15 Establishing Analytical Specification Pharmacovigilance Claims Substantiation

11:15–12:30



Networking Lunch


12:45–2:30 Process Validation Methods in Toxicology Topics in Labels and Labeling

2:30–3:00



Afternoon Break with JAHC Attendees


3:00–4:30 Finished Product Testing/Content Uniformity Populations and Routes of Administration Enforcement Hot Topics

4:30–5:00



Closing Session


5:00–6:30 Joint American Homeopathic Conference Opening Reception (cash bar)

Booking Information

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.

https://www.jahc2019.org/hotel-information.html

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.

Details

Start:
June 27
End:
June 28
Website:
https://www.jahc2019.org/aahp-summit.html

Venue

The Hilton Baltimore
401 W. Pratt Street
Baltimore, MD 21201
+ Google Map
Phone:
443-573-8700