This year’s Virtual Summit focuses on identifying and closing technical gaps that are challenges for both industry and FDA investigators during inspections. While the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) works on resolutions, AAHP has committed to engaging the industry and communicating progress. The 2020 Summit is the first installment along this path.
Join industry and government officials to discuss quality topics for homeopathic drug products during this powerful one-day investment. Through in-depth presentations and by opening a dialog on these topics, safeguard your business by exploring solutions to compliance gaps that are not otherwise addressed within regulations or FDA guidance.
Who Should Attend
The Summit is customized for staff at homeopathic manufacturers, or businesses and consultants for this pharmaceutical industry, related to manufacturing and labeling compliance.
This is a must-attend for:
- Quality Staff
- Product R&D Staff
- Legal & Regulatory Staff
- Company Leaders (President/CEO)
Virtual Session Details:
Recent Trends in FDA Inspections of Homeopathic Drug Manufacturers
Hear thoughts on gaps, solutions, and observations from field inspections from Francis Godwin of the FDA.
About the Presenter
Francis Godwin, MBA
Director, Office of Manufacturing Quality, Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Francis Godwin has served in various functions within FDA in CDER’s Office of Compliance, and is currently the Director of the Office of Manufacturing Quality. He oversees regulatory and enforcement actions for both foreign and domestic drug CGMP cases. He joined FDA after receiving an MBA from Georgetown University in 2009. Prior to this, Mr. Godwin worked as a process engineer designing, building, and optimizing chemical plants after receiving his undergraduate degree from MIT in Chemical Engineering in 2001.
Initiative to Develop Guidelines for HPUS and Homeopathic Manufacturer
Homeopathic products are manufactured through extensive attenuation steps where the starting material diminishes through these steps. Since the final product is usually formulated with extremely low concentration of the analyte, appropriate laboratory testing of satisfactory conformance to final specifications for the drug product is not always possible. Since some of the homeopathic starting materials present risks of toxicity, HPCUS has taken the initiative to develop and establish guidelines and whitepapers for manufacturing process controls and product release for homeopathic manufacturer.
What You Will Learn
- Presenting HPCUS initiative to establish guidelines for homeopathic manufacturer.
- Providing an overview of the guidelines for five categories critical for manufacturing homeopathic drug products.
- Guidelines are recognizing the unique challenges associated with homeopathic products advancing the assurance of product quality and safety.
About the Presenter
Dr. Bibak is the VP of Research & Development at Hyland’s. She earned her master’s degree in Organic Chemistry from Linkoping University in Sweden and a Ph.D. in Pharmaceutical Chemistry from Heidelberg University in Germany. Dr. Bibak has more than 15 years of experience at major pharmaceutical companies, including Par Pharmaceuticals, Bristol Myers Squibb, AstraZeneca, and Allergan, where she worked on drug development. During her career, she has developed and validated hundreds of analytical methods, established drug product stability, specifications and release testing, ensuring product safety and efficacy. Dr. Bibak is also an adjunct faculty at SCNM.
Developing Guidance for Manufacturing Homeopathic Products
Part II of the afternoon will discuss science-based options to reduce complexity in every phase of inspection, testing and validation of homeopathic manufacturing processes. The safety of homeopathic medicines should not be taken for granted simply because these medicines are typically highly diluted when administered. In the majority, the potential hazards of homeopathic medicines can be organized as risks associated with the source materials (raw materials) and as risks associated with the finished product manufacturing procedures. The HPCUS has undertaken an initiative to develop whitepapers and establish guidelines for topics specific to control of homeopathic drug manufacturing to enhance the assurance of product quality and safety. This presentation will provide an in-depth look at topics being considered for inclusion in the testing guidelines.
What You Will Learn:
- Topics being considered for guidelines: 1) Establishing requirements for receiving, testing and storing the Active Pharmaceutical Ingredients used for manufacturing homeopathic products and 2) Required finished product release testing procedures based on product safety and risk-assessment.
- Testing technologies appropriate to the proposed requirements.
- Opportunities to leverage validation and supplier qualification.
About the Presenter
Adam W. Grobin Ph.D.
Dr. Grobin is an independent consultant in the area of drug development/chemistry, manufacturing, and controls (CMC). He earned his bachelor of sciences in Chemistry from Boston College and a Ph.D. in Analytical Chemistry from Duke University working under C. H. Lochmüller before joining Pfizer Central Research (1990, Groton, Connecticut). Dr. Grobin has more than 30 years of drug development experience and has held senior director roles at Eisai Inc., Allergan, and Neurocrine Biosciences. During his career he has held pivotal roles in the development and approval of five new molecular entities.
Summit Welcome and Perspective
Vice President, Government and Regulatory Affairs, Boiron USA
The retirement of the 1988 CPG 400.400 and two versions of a new draft guidance has prompted much examination by the industry into the regulations and compliance issues. Mark Land, who celebrated his 40th year in the industry this year, will provide perspective on the past couple years and how it helped identify six technical gaps in compliance. He will set the stage for what you need to take away from this year’s Summit’s to prepare for the future.
Special Introduction of Presenters and of HPUS Project
by Jay Borneman
Legal and Regulatory Committee Chair, AAHP
Chairman and CEO, Standard Homeopathic Company and Hyland's, Inc.
Industry Reception and Award Presentation:
Presentation of AAHP Integrative Medicine Award to
Derrick Shaffer, Category Manager, Rite Aid Corporation
The award recognizes a person or retailer that promotes and sells products that encompass a broad range of therapeutic approaches to achieve optimal health and wellness for those consumers seeking to participate actively in their healthcare. Remarks and Q&A to follow.
Business Report: State of the Homeopathic Retail Industry
Scott Emerson, CEO and Founder, The Emerson Group
Scott R. Emerson is Founder and CEO of The Emerson Group and its subsidiaries, Emerson Healthcare and Emerson Marketing. His 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.
Submit Your Questions
Virtual Event Schedule and Tickets:
|Reception/Award Presentation 11:00 a.m.||Welcome Remarks by Mark Land. AAHP President and Boiron USA Vice President, Government and Regulatory Affairs|
|11:15 a.m.||State of Retail by Scott Emerson, CEO and Founder, The Emerson Group|
|11:35 a.m.||AAHP Integrative Medicine Retailer Award Presentation to Derrick Shaffer, Category Manager, Rite Aid Corporation|
|12:15 p.m.||Lunch Break|
|Summit 12:45 p.m.||Summit Welcome and Industry Perspective on Technical Gaps by Mark Land, AAHP President and Boiron USA Vice President, Government & Regulatory Affairs|
|12:55 p.m.||Speaker Introduction by Jay Borneman, AAHP Legal and Regulatory Committee Chairman; HPUS Chairman; Standard Homeopathic Company and Hyland’s Inc. Chairman and CEO|
|1:00 p.m. Presentation followed by Q&A||Speaker Topic: Initiative to Develop Guidelines for HPUS and Homeopathic Manufactures by Emily N. Bibak, Ph.D., Vice President, Research & Development, Hyland’s, Inc., a division of Standard Homeopathic Co.|
|1:55 p.m.||Connections Break|
|2:15 p.m.||Speaker Topic: Developing Guidance for Manufacturing of Homeopathic Products by Dr. Adam Grobin, Independent Consultant|
|3:10 p.m.||Connections Break|
|3:30 p.m. Presentation followed by Q&A||Francis Godwin, MBA, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration|
|4:30-4:45 p.m.||Closing Reception & Cheers by Mark Land, AAHP President and Boiron USA Vice President, Government & Regulatory Affairs|