MILWAUKIE, Ore. — This spring, the American Association of Homeopathic Pharmacists (AAHP) will hold its first Quality & Safety in Homeopathic Manufacturing Summit. This intensive workshop, taking place June 27-28, 2019, in Baltimore, will help homeopathic drug manufacturers develop strategies for complying with new enforcement priorities released by the U.S. Food and Drug Administration (FDA) last year.
The agency released a draft guidance in December 2017, introducing a new risk-based approach to the regulation of homeopathic drug products. FDA is expected to adopt the guidance. Although the homeopathic industry shares the agency’s commitment to protecting public health and mitigating risk, the impending change has created uncertainty among manufacturers—especially since homeopathy has been regulated under FDA’s current Compliance Policy Guide 400.400 for so long.
AAHP’s Quality & Safety Summit will shed light on several issues crucial to complying with the proposed new regulations. Taking place in tandem with the Joint American Homeopathic Conference (JAHC), the AAHP Summit will feature separate tracks for quality, safety, and regulatory professionals. The quality track will feature topics like content uniformity and finished product testing. Safety professionals will dive into topics like pharmacovigilance and routes of administration. Finally, those who attend the regulatory sessions will learn about claims substantiation, issues with labeling, and other enforcement hot topics.
“Now more than ever, it is time for the homeopathic industry to come together and learn best practices and new approaches for manufacturing our products,” said Mark Land, AAHP president. “The focused program should provide attendees ample interaction with knowledge leaders and peers alike—all at a fraction of the cost it would require for individual companies to hire consultants.”
The event will include an opening reception on the evening of June 27 as well as opportunities to network with attendees of JAHC, the largest gathering of the American homeopathy community.
Registration will open in the coming weeks. For updates, visit the Quality & Safety in Homeopathic Manufacturing Summit events page. Additionally, AAHP is soliciting speakers for the event. Inquiries may be sent to email@example.com.
Founded in 1923, the American Association of Homeopathic Pharmacists (AAHP) is the leading industry association for the manufacturers, distributors and marketers of homeopathic drugs. AAHP promotes excellence in the practice of homeopathic pharmacy, manufacturing, marketing and distribution by supporting the requirements, criteria and published guidelines in the HPUS, relevant Federal statutes, as well as other industry regulations/compendia — all to help members provide safe, effective homeopathic medicines to consumers, retailers and healthcare practitioners.