Does your company experience a gap between 21 CFR cGMP requirements and the pragmatic realities of implementation for homeopathic drug products? AAHP, in partnership with the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), has identified five such technical gaps that are challenges for both industry and FDA inspectors.
In continuation of this industrywide, multi-year effort, the 2021 Summit will present virtually:
- Concept Paper: Process Validation for Preparation of Hahnemannian Liquids
- White Paper: Control of Active Pharmaceutical Ingredients
- Views on these pharmaceutical quality issues and necessary compliance considerations by Richard Lostritto, PhD, Associate Director for Science, Office of Policy for Pharmaceutical Quality at FDA’s CDER.
HPCUS-AAHP Partnership
The HPCUS is a non-governmental, non-profit scientific organization composed of experts in the fields of medicine, arts, biology, botany, chemistry, and pharmacy who have demonstrated additional knowledge in the principles of homeopathy. This standards-setting organization for homeopathic pharmacy is responsible for continually updating the HPUS which contains official manufacturing techniques for all recognized product types and dosage forms of homeopathic drug products sold in the United States.
The discussions with FDA in 2018 and 2019 are guiding the HPCUS efforts in further harmonizing the practice of homeopathic manufacturing with current FDA guidelines and the agency’s expectations. As HPCUS provides the science and content to these critical issues, AAHP educates and engages the industry on the progress. The 2021 Summit is the second installment along this path.
Missed Last Year’s Summit? Get Two for the Price of One!
It’s free and easy to get up-to-speed. A complimentary recording of Summit 2020 is included in the registration for Summit 2021. Don’t be left behind as the industry and the standard-setting organization come together to mold our future.
Who Should Attend?
The Summit is customized for staff at homeopathic manufacturers and marketers, or businesses and consultants for this pharmaceutical industry. While the focus is related to manufacturing and quality, the content and application is also critical for other parts of your organization.
This is a must-attend for:
- Quality Staff
- Legal & Regulatory Staff
- Production Leads
- Product R&D Staff
- Company Leaders (President/CEO)
DATE
Tuesday, June 15, 2021
TIME
1:00 p.m. - 5:00 p.m. EDT
PLACE
Virtual Zoom Platform
Featured Speakers
KEYNOTE PRESENTATION:
A Perspective on the HPUS Project
As the keynote speaker, Dr. Richard Lostritto of the U.S. Food and Drug Administration (FDA) will close the Summit with input on the day’s topics and take Q&A. This session is an important continuation of the discussion and work being done between FDA and the homeopathic industry. Dr. Lostritto’s views on these pharmaceutical quality issues and necessary compliance considerations will greatly benefit all attendees.
Richard (Rik) Lostritto, PhD
Associate Director for Science
Office of Policy for Pharmaceutical Quality (OPPQ)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Dr. Lostritto joined FDA in 1995 and currently serves as Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously, Dr. Lostritto served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy, Biopharmaceutics Lead, CMC Division Director (oncology, hematology, cardio-renal, neurology, and psychiatric drug products), Team Leader (pulmonary, allergy, and oncology drug products), and Review Chemist in several therapeutic areas. Prior to joining FDA, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant/Associate Professor of Pharmaceutics at the University of Connecticut School of Pharmacy.
SESSIONS AND SPEAKERS:
Update and Outlook on Developing 5 Guidelines of HPUS and Homeopathic Manufactures
At AAHP’s September 2020 Summit, Dr. Nelly Bibak presented an overview of HPCUS’s work to harmonize practical manufacturing, HPUS, and FDA’s guidelines within five technical areas of unique challenges for homeopathic manufacturers. Where are we today on this multi-year effort? Dr. Bibak will give a brief status update on the initiatives that will advance the assurance of product quality and safety.
What You Will Gain
- Knowledge of areas in which your company may need to invest to prepare for the future.
- A head start competitive advantage on what SOP and validation modifications may be necessary.
- An overview of the upcoming steps being undertaken by the HPCUS.
Emily N. Bibak, PhD
Director of Analytical Development
Epirium Bio
Dr. Bibak is the former Vice President of Research & Development at Hyland’s. She earned her master’s degree in Organic Chemistry from Linkoping University in Sweden and a PhD in Pharmaceutical Sciences from Heidelberg University in Germany. Dr. Bibak has more than 17 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 Southwest College of Naturopathic Medicine.
Concept Paper: Process Validation for Preparation of Hahnemannian Liquids
Participation is encouraged in this session, which will be the basis of a forthcoming white paper anticipated at the 2022 AAHP Summit. The future white paper will define required procedure steps, variables, and controls necessary to validate the Hahnemannian attenuation manufacturing process.
Discussions/Learnings
- Scope of the validation project.
- Historic and current regulatory requirements.
- Analytical challenges.
- Proposed approaches to process validation for Hahnemannian liquid attenuations.
Isabelle Chanel
Director, Product Development and Regulatory Affairs
Boiron France
Ms. Chanel is Director of Product Development within Boiron’s Global Regulatory Group. She earned her chemical engineering degree from The Chemical and Physical School of Lyon and a master’s degree in analytical chemistry from Lyon University. Ms. Chanel has been involved with the development of homeopathic drug products for more than 20 years. She has been a member of the HPUS since 2017 and participates in the Council on Pharmacy and the Standards and Controls Committees. Prior to joining Boiron, Ms. Chanel was an application engineer and Business Development Manager in analytical technologies for Hewlett Packard and Agilent Technologies respectively.
White Paper: Control of Active Pharmaceutical Ingredients (API)
Manufacturers of homeopathic medicines lack detailed guidelines for APIs such as starting materials, active drug substances, and especially intermediate and high attenuations in powder or liquid form. Guidelines are necessary to ensure the received materials comply with the recipient’s expectations and applicable regulatory requirements. At the September 2020 Summit, Dr. Adam Grobin presented a concept paper and facilitated an industry discussion on this topic. This year, he will present the white paper on establishing requirements for APIs.
What You Will Gain
- Guidelines that encompass the topics listed under 21 CFR 211 Subpart E-Control of components and Drug Product Containers and Closures.
- Time-savings when evaluating the implementation of necessary controls for APIs.
- Knowledge of what is appropriate for homeopathic drug products given the range of potential attenuations.
- An overview of critical considerations to evaluate regarding APIs not adequately addressed in 21 CFR 211.
Adam W. Grobin, PhD
Independent Consultant
Dr. Grobin is an independent consultant in drug development/chemistry, manufacturing, and controls (CMC). He earned his bachelor of science in Chemistry from Boston College and a PhD 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.
HPUS: A Historical and Current Project Overview
FDA’s revised Draft Guidance and definition of what is and what is not homeopathic is based on the Homeopathic Pharmacopoeia of the United States (HPUS). Thus it is more important than ever for your company to be in-the-know on priority projects from this scientific and standards-setting organization. All manufacturers and marketers of homeopathic drug products must be aware of upcoming changes that may affect your business, your cGMP compliance, your products, and your long-term success in the market.
What You Will Learn
- HPUS changes on the horizon.
- How this long-term HPUS project will affect your business and the timeline of the project’s various steps.
- A preview of another AAHP-HPUS educational collaboration on compliance in Fall 2021.
William Shevin, MD, DHt
HPCUS President
Dr. Shevin holds medical licenses in Connecticut, both as a conventional physician and as a homeopathic physician. He has practiced medicine since 1974 and homeopathy since 1981. Dr. Shevin is the past president of the National Center for Homeopathy and served on NCH’s faculty for several years. He is a long-time member of the American Institute of Homeopathy and has served as an HPCUS Board of Director since 1987. In April 2021, he assumed the presidency of HPCUS.
Welcome and Vision for the Future
Tune in early as our moderator sets the stage for the day and this multi-year industry collaboration to safeguard your business. The horizon for the industry is laid out: challenges have been identified; subject experts are facilitating discussions through concept papers; and research and industry feedback will culminate in white papers.
What You Will Learn
- The importance of staying engaged in this process to safeguard your business.
- What you need to take away from this year’s Summit’s to prepare for the future.
- What other opportunities AAHP is providing in 2021.
Mark Land
President, AAHP
Vice President, Government and Regulatory Affairs, Boiron USA
Mr. Land has represented the manufacturers’ voice to national regulators and legislators in Washington DC as AAHP’s volunteer president for 15 years. He is also Chairman of the HPUS Monograph Review Committee. During his 41 years in the homeopathic pharmaceutical industry, Mr. Land has built an expertise in the areas of legal, regulatory, manufacturing, quality control, and distribution of homeopathic drug products.
Virtual Event Schedule and Tickets:
| Time | Speaker | Topic |
|---|---|---|
| 1:00 p.m. ET (10 a.m. PT / 7 p.m. CET) | Mark Land, MS, RAC President, AAHP Vice President, Government and Regulatory Affairs, Boiron USA | Welcome and Vision for the Future |
| 1:15 - 1:30 | William Shevin, MD, DHt HPCUS President | HPUS: A Historical and Current Project Overview |
| 1:30 - 1:40 | Emily N. Bibak, PhD Director of Analytical Development Epirium Bio | Update and Outlook on Developing 5 Guidelines for HPUS and Homeopathic Manufactures |
| 1:40 - 2:35 | Isabelle Chanel Director, Product Development and Regulatory Affairs Boiron France | Concept Paper: Process Validation for Preparation of Hahnemannian Liquids |
| 2:35 - 2:50 | Break | |
| 2:50 - 3:45 | Adam W. Grobin, PhD Independent Consultant | White Paper: Control of Active Pharmaceutical Ingredients |
| 3:45 - 4:00 | Break | |
| 4:00 - 4:55 | Richard (Rik) Lostritto, PhD Associate Director for Science Office of Policy for Pharmaceutical Quality (OPPQ) CDER, FDA | A Perspective on the HPUS Project |
| 4:55 - 5:00 | Mark Land, MS, RAC | Close of Summit |