AAHP-Summit-Brochure

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Proudly celebrating 25 years as your strategic partner for accelerating mid-market brand growth.

We manage a $4 billion HBC portfolio which provides the scale to efficiently leverage trends and insights in the development of category-leading growth plans for our clients. Over the past three years, the Emerson Group portfolio has grown 1.7X the HBC category.

Expert Sales Leadership Category Management The Emerson Group Strategic Sales Planning Shopper Insights & Analytics 1994 E-Commerce Strategy & Management Brand & Shopper Marketing SummitSummit onon Sales Operations Infrastructure Comprehensive Syndicated Data 2019 ChallengesChallenges && SolutionsSolutions For additional information about the advantages of the Emerson Group call Roger Gravitte at 610.971.9600 inin QualityQuality && SafetySafety www.emersongroup.com We’re glad you’re here. ofof HomeopathicHomeopathic DrugDrug ProductsProducts

99 a.m.–5a.m.–5 p.m.,p.m., Friday,Friday, JuneJune 28,28, 20192019 HiltonHilton BaltimoreBaltimore

#SafetySummit#SafetySummit #Homeopathy#Homeopathy AAHP_Program_11x17_Final6:Layout 1 6/25/19 2:37 PM Page 3

Welcome to the AAHP Summit Nelson Bach USA Ltd. Terravitals R • Carol Wasteneys, Regulatory and Quality Mgr. • Navid Pezeshkzad, Homeopathic Consultant • Denise Eaton, Bach Brand/Education Mgr. Welcome to the AAHP Summit! The Summit was designed specifically for • John Ende, General Manager The Emerson Group homeopathic manufacturers and our special challenges with high dilutions. • Scott Emerson Everyone in this room should be congratulated as a leader in the industry by OHM Pharma, Inc. coming together for an open exchange to solve our challenges. • Justyna Mazur, Dir., Regulatory Compliance • Robert Melo, President The Markens Group • Brian Westerlind, Communications Manager Procter & Gamble We have a responsibility to produce products of the highest quality so that consumers • Emily Leonczyk, Director of Marketing • Adrian Land and families across the U.S. and the world receive the full health benefits of homeopathy without safety risks or questionable reliability. To all the quality and Propulsora de Homeopatia TRP Company regulatory staff here today with their top management, this should be your • Javier Lopez • Stephen Pike, Supply Chain Strategist everyday mission: To minimize risk by manufacturing based on sound quality and • Jesus Navarro, CEO U.S. Food and Drug Administration safety principles. RB Health • Francis Godwin, Director, OMQ • Donna Alvarez, Senior Regulatory Associate • Elizabeth Kelley, Regulatory Counsel AAHP has assembled the highest quality information on these topics in a format Racher Press (Chain Drug Review) • Tamara Ely, Consumer Safety Officer that is responsive to attendees needs and regulators expectations. Please make the • Andrea Fallin, Director most of this opportunity. Our discussions here will affect the future, providing • Mark Baumgartner, Senior Editor Van Scoyoc Associates retailers, practitioners and consumers better, safer, reliable products for their Similasan Corp • Pete Evich, Vice President wellbeing. • Dan Quail, President • Kimberly Stark, Dir., Quality & Regulatory Affairs Washington Homeopathic Products • Yann Pigeaire, Vice President, Marketing • Belle Noorzai, Dir., Sales & Marketing Standard Homeopathic/Hyland's • Linda Lillard, President • Alison McPeak, Manager, Pharmacy • Wais Noorzai, Quality Assurance Manager • Jay Borneman, CEO Mark Land • Les Hamilton, President Wegmans Food Market, Inc. AAHP President • Mary Borneman, Sr. Dir., Comm. & Public Affairs • Katie Niles, Healthcare Category Merchant • Eric Baier, Sr. V.P., Regulatory & Technical Affairs • Karen Shadders, V.P., Health, Wellness, Home & Entertaining • John Karl Schlottig, Director of Process Validation • Mark Phillips, Vice Chairman Weleda, Inc. • Stephen Reta, Regulatory Affairs Manager • Petra Augenstein Tec Labs • Mary Cha, Regulatory Affairs Whole Foods Market • Nikki Frum • Lee Mayberry, Global Legal Regulatory Coordinator

Thank You 2019 AAHP Board of Directors!

President - Mark Land, Boiron USA Treasurer - Mark Phillips, Standard Homeopathic/Hyland's Secretary - Eric Foxman, Eric L. Foxman Consulting

Members of the Board Travis Borchardt, Nature’s Way Mary Borneman, Standard Homeopathic/Hyland's Denise Eaton, Nelson Bach USA Ltd. Guillaume Lois, HBC Naturals Dan Quail, Similasan Corp Mary Beth Watkins, Emeritus AAHP_Program_11x17_Final6:Layout 1 6/25/19 2:37 PM Page 5

Attendees of the AAHP Reception and Summit Opening Keynote: Francis Godwin, MBA, Director, Office of Manufacturing Quality, AmerisourceBergen Homeopet Office of Compliance, Center for Drug Evaluation and Research, • Doug Trueman, V.P., Consumer Products • Aindriu Farrington • Jim Beck, Director • Ingrid Semino, Supply Chain Manager U.S. Food and Drug Administration After receiving his undergraduate degree from MIT in Chemical Engineering in 2001, Francis Godwin worked Informa (Pink Sheet and HBW Insight) Boiron as a process engineer designing, building, and optimizing chemical plants. In 2009 he received an MBA from • Eileen Francis, Reporter • Alissa Gould, Dir., Corp. Comm. & Public Affairs Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. Francis has • Malcolm Spicer, Consumer Health Writer • Fanny Guillot, Manager, Regulatory Affairs served in various functions within compliance, and is currently the Director of the Office of Manufacturing • Gary Wittenberg, V.P., National Accounts Little Big Brands Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases. • Janick Boudazin, President & CEO • Katie Littlefield, Business Development Acc. Dir. • Katie Lopez, Account Director • Kristina Skowronek, Dir., Quality & Regulatory Compliance AAHP Inaugural Industry Reception • Mark Land, V.P., Government & Regulatory Affairs Lorman Law DC • MaryEllen Tefft, Director of Sales-FDM • Al Lorman 5–7 p.m., Thursday, June 27 • Melissa Boyle, Regulatory Administrative Specialist MAI Consulting, Inc. Hilton Baltimore Carroll Room overlooking Camden Yards • Ray Petrick, Vice President of Sales • George Bernstein, President • Scott Bradley, Regional Account Manager, Mid-Atlantic AAHP’s special evening reception celebrates its inaugural Summit with senior executives from the homeopathic industry and other special • Jan Owens guests. Remarks from thought leaders include: • Scott Osborne, Dir., Strategic Account Development • Stacey Kelly, Quality Assurance Manager Matrixx Initiatives • Stephanie Chanut, Analytical Methods Dev. Lab. Mgr. • Arlene Ascarate, Director of R&D • Public Policy; What We Have Learned • John Clayton, Regulatory Consultant Scott M. Melville is President and CEO of the Consumer Healthcare Products Association. He leads CHPA’s Brandperx • Lou Fraser, Director of Quality Assurance efforts to preserve and expand choice and availability of consumer healthcare products. He was previously • Mark Collins, National Account Director • Tim Clarot, Sr., V.P., R&D and Product Quality SVP of government affairs and general counsel for the Healthcare Distribution Alliance, has held public Medinatura Inc. affairs and legal roles for Sterling-Winthrop, Hoffmann-LaRoche, and Cephalon, and has been a legislative Coelus, LLC assistant for a Member of Congress. He earned his bachelor’s degree in economics and political science • Cathy Raish, V.P., Regulatory/Quality • Matthew Reed, Principal from Bucknell University, and his juris doctorate from George Mason University. • Elena Elliott-Hind, QC Lab Manager Consumer Healthcare Products Association Miers Laboratories • Barbara Kochanowski, Sr., V.P., Regulatory & Scientific Affairs • Andrew Criglington • Jay Sirois, Sr. Dir., Regulatory & Scientific Affairs • Michael Dong • Business Report: State of the Homeopathic Retail Industry • Scott Melville, President & CEO Scott R. Emerson. Mr. Emerson is the founder and CEO of The Emerson Group and its subsidiaries, Emerson Morgan Lewis & Bockuis Healthcare and Emerson Marketing. The Emerson Group is a forward-thinking consumer products equity CPG Linkages, LLC • Ann Begley, Partner organization which manages CPG brands in excess of $4 billion, and holds equity positions with small and medium- • Ted Peterson, President size brands. (See sponsor section for company information.) Mr. Emerson has over 30 years’ experience with Nartexlabs companies including Johnson & Johnson, Unilever and Novartis Consumer Health. Prior to founding the Emerson • Eduardo Acosta, CEO Customer Marketing Group Group, he has held senior management positions in Fortune 500 companies within brand management, • Bruce Montgomery, General Manager National Association of Chain Drug Stores new business development, sales operations and field sales. He received his B.A. in Accounting and Business Management from Texas State University. ECRM • Jim Whitman, Sr., V.P., Member Programs & Services • Wayne Bennet, Sr., V.P., Retail National Center for Homeopathy Board of Directors • Presentation of AAHP Interactive Medicine Award to Wegmans Food Markets, Inc., and remarks from • Abby Beale, Past-president Eric L. Foxman Consulting recipient Karen Shadders, Vice President, Health, Wellness, Home & Entertaining. The award recognizes a • Christina Donka, Board Member retailer that promotes and sells products that encompass a broad range of therapeutic approaches to • Eric Foxman, AAHP Secretary • Deb Dupnik, Executive Director achieve optimal health and wellness for those consumers seeking to participate actively in their healthcare. FDA Connect • Fabrice Figliolini, Board Member • Leonard Krause, President • Glenna Tinney, Board Member • Lauri Grossman, President-elect GRAS Associates LLC, a Nutrasource Co. • Loretta Butehorn, Secretary JACH Reception, Networking Breaks and Lunch • Amy Mozingo, Director of Operations • Lynn Wagner, Board Member • Tina Quirk, President The AAHP Summit provides several opportunities to exchange ideas with fellow manufacturers, build Guna Spa relations with a retailer, or hear directly from practitioners and consumers attending the Joint Annual • Alan Lucero, U.S. Agent Natural Creations Homeopathic Conference. • Jordan Short, Quality Control • Sofia Pizzoccaro, Regulatory Affairs Director Lunch (11:45 a.m.–1:00 p.m.): Self-served boxed lunches will be available. There are two choices: • William Steppuhn • Stella Pizzoccaro, International Sales Manager • Chipotle grilled chicken on a Kaiser roll with cheddar, lettuce, tomato, chipotle aioli. Natural Immunogenics Corporation • Grilled vegetables and goat cheese with arugula on a gluten-free wrap. Hahnemann Labs, Inc. • Nan Qin, R&D Manager/Scientist • John Feiseel Both boxed lunch choices include a penne primavera salad, sugar cookie, a whole fruit, and an individual Nature’s Way bag of chips. An assortment of soft drinks and bottled water are also available. HBC Naturals • Kate Nass, Supply Quality Team Lead Breaks and Reception with attendees from the JAHC: AAHP’s two coffee breaks are coordinated with JAHC’s breaks. • Guillaume Lois, CEO • Sara Miyasaki, Regulatory Affairs Supervisor Additionally, AAHP attendees are cordially invited to JAHC’s cash bar reception, 5:00–6:30 p.m., Friday, June 28. AAHP_Program_11x17_Final6:Layout 1 6/25/19 2:37 PM Page 7

Workshop Choices 10:15–11:45 a.m. Event Supporters

Quality Track Safety Track Regulatory Track Eric L. Foxman Consulting Tubman A & B Meeting Rooms Stone Meeting Room (Live Video) Chase Meeting Room https://sites.google.com/site/ericlfoxman/home Using in-depth expertise from decades of positions within HPCUS and AAAP, Eric Foxman, RPh, offers private consultations to find solutions to our industry’s special compliance challenges. Eric helps Analytical Development Challenges in Best Practice Post Market Surveillance and Homeopathic Product Substantiation companies comply in the areas of labeling design/text, with the HPUS, and cGMP through reviews of Homeopathy: Detect and Quantify Quality, the Ongoing Process of Monitoring, from Concept to Shelf literature, protocols, and manufacturing technologies. He is also available to serve as a spokesperson in and Toxicological Markers Assessing and Confirming Product Safety Presented by Amy Mozingo, MS, Director these areas. Presented by Stéphanie Chanut, Presented by Richard Kingston, PharmD, of Operations, GRAS Associates LLC, Pharmaceutical Development Laboratory President, Regulatory and Scientific Affairs, a Nutrasource Company Manager, Boiron (France) SafetyCall International, PLLC, & Clinical Professor of Pharmacy, University of Minnesota Coelus LLC In light of FTC’s disclaimer request, what can the The most frequently cited GMP deficiency during homeopathic industry learn from the supplement www.CoelusBio.com homeopathic facility inspections in 2018 was 21 Simply meeting regulatory requirements may not industry? When bringing products to market, it is Our staff conceptualizes and facilitates early to late phase development of pharmaceutical intellectual CFR 211.160(b): “lack of scientifically sound aid the manufacturer in the detection and essential to build a platform that allows all property and provides consulting services in integrated drug development strategies, toxicology, and laboratory controls.” This workshop will review mitigation of the most serious threats affecting a information generated to be available for future pharmacology. We specialize in applying our expertise to pharmaceutics, due diligence, pharmaceuti- the presenter’s research with various analytical company’s product and brand. This presentation use. Manufacturers and labelers will learn about cal-related government grants and contracts, inhaled drug development, inhalation and general methods applied to homeopathic active reviews best practice post-market surveillance at factors in substantiating claims and which toxicology, and human health hazard assessment. ingredients and dosage forms. Examples will be a corporate level, and how implementation can aid business partners are held responsible in the eyes provided using case studies of the detection of in the detection, management, and mitigation of the law. FTC history and “no-nos” are reviewed CPG Linkages, LLC alkaloids and other characteristic constituents of the most serious product safety threats a before closing with a comparison of regulations in tinctures, dilutions and finished products. company may face. for homeopathy in the U.S., Canada and the U.K. www.CPGlinkages.com Connecting senior-level association, manufacturer and retailer executives through targeted 1:1 meet- ings, annual industry overviews, conferences and other opportunities to drive mutual business growth. What You Will Learn: What You Will Learn: What You Will Learn: • Regulatory background of homeopathic • Key principles behind Best Practice Post- • Substantiation per FTC and FDA guidance. Morgan, Lewis & Bockius LLP drug products. Market Surveillance. • How to develop a substantiation file. www.MorganLewis.com • Manufacturing techniques for finished • Thinking outside the box in the application • What types of claims you can make. products and the purpose of the analytical of safety signal detection. The Washington, D.C. office of our global law firm specializes in the law involving the intersection of • How to navigate the regulatory environment development. business and government. Many of our lawyers are former senior government officials and our • How to identify and separate “background while still providing true homeopathic products. • Detection, identification and quantification noise” from emerging threats when analyzing nationally recognized talent includes a former FTC chairman. Our lawyers interact daily with agencies of analytical markers in tinctures. spontaneously reported adverse events. of the government on FDA, healthcare, and life sciences issues, and much more. • Analytical techniques from tincture to • How to package and communicate the About the Presenter dilutions and finished products. adverse event experience into a positive Amy Mozingo, MS, Director of Operations, GRAS Nutrasource product safety message. Associates LLC, a Nutrasource Company, has more www.Nutrasource.ca than 15 years of experience in industry and About the Presenter consulting related to FDA regulated products Nutrasource is your one-stop shop for health product development and market entry services — from Now in her 13th year at Boiron, Stéphanie About the Presenter (food, supplements, cosmetics, homeo- concept to claim. Through our vertically-integrated service platform, we offer full regulatory, clinical, and Chanut manages a team responsible for Dr. Kingston has 40 years’ experience in clinical pathic/OTC). She holds a certificate as a testing solutions for products ranging from dietary supplements to pharmaceuticals in Canada, the analytical development, stability studies, and toxicology and pharmacology, poison control, Preventive Control Qualified Individual and is U.S., and Europe. liquid and gas chromatography set-up. She product post-market surveillance, and drug and trained and experienced in safety evaluations, previously worked as a Regulatory Affairs dietary supplement safety. He has helped shape ingredient approvals (GRAS, NDIN, FAP, CAP), SafetyCall International, PLLC Manager Engineer at Boiron. Stéphanie started national policy on a variety of critical issues product labelling, formulation reviews, claims her career at Sanofi Pasteur and then Merck related to product safety. Richard also co-founded substantiation and current good manufacturing www.SafetyCall.com Generics in technical regulatory affairs. SafetyCall after holding top leadership roles in requirements for dietary supplements. Founded in 2004, SafetyCall is the world’s largest 24/7 Adverse Event call center, and a leader in academia and the Minnesota regional Poison Adverse Event Management and Post-Market Surveillance services. We provide immediate access to Center where he gained critical care toxicology clear and trusted health, safety, and medical information to clients and their customers. Our clients experience while range from dietary supplements to industrial products to animal health products. practicing in a University- affiliated Level One Trauma Van Scoyoc Associates Center. www.VSAdc.com VSA is a bipartisan, bicameral government relations firm with talented and experienced policy experts, who provide comprehensive and strategic services encompassing all aspects of the federal process. VSA’s experts have hundreds of years of combined experience and bring an insider’s knowledge of Capitol Hill and the Executive Branch. AAHP_Program_11x17_Final6:Layout 1 6/25/19 2:37 PM Page 9

Workshop Choices Sponsors of the AAHP Reception & Summit 1:00–2:30 p.m.

Quality Track Safety Track Regulatory Track PRESENTING SPONSOR Tubman A & B Meeting Rooms Stone Meeting Room Chase Meeting Room

Process Validation: Topics in Labels and Labeling What Is It for Homeopathic Products? Part I: Principles of Toxicology Presented by Eric L. Foxman, RPh, Regulatory The Emerson Group Co-presented by Eric Baier, Senior Vice Presented by Matthew D. Reed, PhD, DABT, Consultant, Secretary for American Associa- www.EmersonGroup.com President, Regulatory and Technical Affairs, Fellow ATS, Principal, Coelus LLC tion of Homeopathic Pharmacists, and Senior and Karl John Schlottig, Director, Scientist for Homeopathic Pharmacopeia The Emerson Group is a consumer products equity organization focused on accelerating mid-market brand growth. It also operates internationally, Process Validation, both at Hyland’s Inc., Convention of the United States providing partners in the European, South American and Asian Pacific regions with the expertise and infrastructure necessary to successfully oper- a division of Standard Homeopathic Co. How do precedents for methods of determining ate in the U.S. market. An Emerson Group division, Emerson Logistics is a consumer products logistics solutions provider. A third division, Emerson safe human exposure and dose levels pertain to Marketing, is an analytics and insights-based consumer products communications organization. FDA’s emphasis on certain botanicals with Validation approaches changed with FDA’s 2011 potentially toxic alkaloids? Matt’s presentation will FDA’s draft guidance states the agency’s Guidance. Learn key differences between this prepare you and your staff with the background enforcement actions will focus on various types PLATINUM LEVEL SPONSORS guidance and previous practices. After a survey of and information necessary to understand and of products, including those associated with the requirements, many of the unique challenges perform in-house confirmation of the HPUS first otentially significant safety concerns; those and considerations for homeopathic manufactur- OTC attenuations in line with international intended for the prevention or treatment of ers will be discussed, including what you must assessment standards, so you can be certain your serious and/or life-threatening diseases and know before you begin to develop a successful products are safe for sale to consumers. conditions; and those intended for vulnerable process validation program. This will include the populations. Learn how to minimize risk in these Boiron Hyland’s Inc. pros and cons of different approaches to demon- categroies. www.BoironUSA.com www.Hylands.com strating the effectiveness and consistency of your What You Will Learn: In 1932 in Lyon, France, twin brothers and pharmacists Jean and Henri Founded in 1903 and dedicated to supporting the health and well- processes to auditors. • Overview of risk assessment principles. What You Will Learn: Boiron set out to develop a way to prepare reliable homeopathic ness of families, Hyland’s is a leading homeopathic company in North • Basic tenets of toxicology T=testing. • OTC label format and content requirements. medicines for their patients. Today Boiron continues as an inde- America and a top natural OTC brand. Hyland’s products have been What You Will Learn: • Program design considerations. pendent pharmaceutical laboratory that prides itself on quality man- shared by families for generations. Hyland’s medicines are prepared • Self-medication vs. prescription indications • Process validation defined (old vs. 2011). ufacturing and responsible environmental practices. We are with the highest quality active ingredients and follow strict standards o General regulations and guidelines disease claims: • Process knowledge needed. (pharmaceutical examples). passionate about integrating the benefits of homeopathic medicine of preparation. o Limits of self-medication. into daily life. • How do I get what I need and trade-offs. o Species selection. o Range of self-medication indications. o Specific chemical/product class/use. o Implications on non-self-limiting About the Presenters • Study design considerations. indications on a consumer product. Eric Baier has 25 years of experience in pharma- o Specific design parameters. • See wording and promtional presentation that ceutical manufacturing, FDA has flagged recently to help you set label MAIMAEFFICIENCYEAIFFF ICICIECIEI NCCConsultingY | oCCOMPLIANCEOMMPLIANCEnnsultingnsul ||QUltlti QUQUALITYtALITingY validation, quality and guideposts. technical roles. After About the Presenter MAI Consulting, Inc. Matrixx Initiatives, Inc. working in injectables Matt Reed is the Principal and CEO of Coelus • Review of standard regulatory labeling www.ConsultMAI.com www.Zicam.com and biotech, Eric LLC where he facilitates full phase development requirements. MAI Consulting Inc. in Chapel Hill, N.C., helps homeopathic manu- Matrixx Initiatives has been engaged in the development and joined Hyland’s in of pharmaceutical IP and provides consulting 1997 as Production facturers prevent inspection problems before they arise and address marketing of better ways to feel better through over-the-counter services in toxicology, pharmacology, and About the Presenter existing compliance issues. As a pharmaceutical consultant, Dr. health care products for over 20 years. Matrixx Initiatives manufac- Manager and has hazard assessment. Dr. Reed is a pharmacologist, George Bernstein, PhD, works to improve the efficiency, compliance, tures and markets Zicam® brand homeopathic OTC products, served as Plant Manager board certified toxicologist, ABT Board Eric L. Foxman, RPh, has been actively engaged as well as Technical Director. and quality of small, medium, and large domestic and global allo- including its clinically proven homeopathic ZICAM Cold Remedy Member, and Fellow-Academy of Toxicology in the homeopathic industry for more than four He became the head of Quality pathic and homeopathic companies. Nasal Spray and Swabs and Cold Remedy RapidMelts®. Sciences. He has more than 25 years’ experience decades, both on the manufacturing/laboratory at Hyland’s in 2012. in transitioning multiple R&D programs through side and on the regulatory/consulting side. He Karl John Schlottig has held senior management regulatory registration milestones. brings his years of experience working with both positions for more than 20 years in manufacturing, domestic and overseas manufacturers and validation, and quality at pharmaceutical and clients to address label- biotech companies such as ing issues of critical Alpha Therapeutics and importance. Nelsons Similasan Corp. Genentech. Karl is skilled www.Nelsons.net www.SimilasanUSA.com in global regulatory Nelsons is the U.K.'s leading manufacturer of natural health care Similasan is dedicated to helping families feel good about feeling compliance; new products, with a long-standing commitment to supplying the high- better. Our natural remedies provide temporary symptomatic relief manufacturing facility est quality natural health care products that meet all regulatory and from ailments of the eyes, ears, nose, head, and chest. Originating in design, construction, commissioning and vali- quality standards. Since 1995, Nelson Bach USA Ltd has been the Switzerland in 1980, the Similasan brand became popular across dation; and sterile product sole North American distributor of RESCUE REMEDY®, BACH® Europe. Today, Similasan remedies are widely used and well-respected processing. Original Flower Remedies and SPATONE®. in North America. 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Workshop Choices 3:00–4:30 p.m. Closing Keynote Speakers A review of the day’s key learnings will be summarized by the Summit’s Track Leaders. This brief- Quality Track Safety Track Regulatory Track ing of all issues is especially educational for companies with only one representative at the Summit who cannot attend all tracks. For others, the overview is a last chance to clarify concepts Tubman A & B Meeting Rooms Stone Meeting Room Chase Meeting Room or interact with the following industry experts.

Moves Toward FDA Requirements: Part II: Application of General Toxicology Enforcement Hot Topics: Track Leaders Establishing Homeopathic Finished Product Studies to Support It’s Not the 483, It’s the Consumer AAHP Summit attendees will gain valuable insight on quality, safety and regulatory issues in Specifications and Shelf Life Regulatory Requirements Presented by Mark Land, MS, RAC, President workshops developed under the guidance of three experts. The limited-seating workshops also Presented by Fanny Guillot, Regulatory Affairs Presented by Matthew D. Reed, PhD, DABT, of American Association of Homeopathic provide easy access to these notable professionals for specific questions. Officer, AMM (marketing authorization) Fellow ATS, Principal, Coelus LLC Pharmacists and Vice President of Government Development Unit, Boiron (France) & Regulatory Affairs, Boiron USA Public safety is FDA’s top priority, as it should be Homeopathy is a singular drug product with for manufacturers too. Building upon the previous FDA’s draft guidance is a shift from a compliance singular challenges. Globally, regulatory officials Safety Workshop, Dr. Reed will detail how toxicol- policy guide to risk-based enforcement. This are drawing upon successful marketing authori- ogy is utilized to determine safe starting doses for workshop will identify areas in which you can Quality Track Leader zation requirements from different parts of the human use comparing and contrasting pharma- properly understand the aims of a pharmaceuti- George Bernstein, PhD world. Fortunately, this convergence of different ceutical and homeopathic approaches. Is your cal quality system and reduce their risk through interpretations and viewpoints is creating a con- company worried about potential litigation an analysis of warning letters, import alerts, President, MAI Consulting, Inc. sistent manner helpful to all involved. Manufac- regarding the safety of your products? Matt’s inspection citations and recalls. The statistics www.ConsultMAI.com turers and private labelers can also use global presentation will equip your company with the will provide insight on the agency’s enforcement Dr. Bernstein’s expertise ranges from GMP compliance, facility design, construction, and commission- synergies to demonstrate quality and safety to tools and background to make a rational and approach and priorities. FTC activities will also ing to business process re-engineering and process optimization. He has developed global quality U.S. health authorities. science-based justification that your products are be examined. standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many safely formulated for sale to consumers. clients with audit preparation, remediation activities, and communications with FDA. And for 30 years, his family (including pets) have used homeopathic medicines. What You Will Learn: What You Will Learn: • Regulatory framework for specifications and What You Will Learn: • Quality systems best practices, checklists, and shelf life. • Principles of toxicology testing applied to profiling to prepare for your next inspection. • Proposed approach through Europe for product development. • Post-inspection programs to reduce risk. Safety Track Leader homeopathic dilutions and finished products. • How these methods are used to support safe • FDA inspection trends (e.g., inspection Mark S. Phillips, Pharm.D. human starting doses. • Establishing specifications for a homeopathic frequency, observations vs. enforcement, Vice Chairman, Standard Homeopathic Company finished product; pharmacotechnical parameters. • Comparing and contrasting pharmaceutical domestic vs. international action). www.Hylands.com • Transposition for stability evaluation of and homeopathic approaches • Where lie the hot topics: data integrity, dilutions and finished products. analytical methods, process validation, Beyond his technical, strategic and advisory contributions at SHC, Mark Phillips is an active leader in AAHP and the Homeopathic Pharmacopoeia Convention of the United States. A third-generation • A regulatory approach in the context of FDA’s adverse event reporting, non-self-limiting indications or supplier management. homeopathic pharmacist, he has guest lecturered on Homeopathic Pharmacy at his alma matter, the new dynamic to provide guarantees as About the Presenter University of Southern California School of Pharmacy, and has authored and presented accredited CE regarding the quality of homeopathic finished • Cost of non-compliance. programs to numerous state and professional pharmacy organizations. products. Matt Reed is the Principal and CEO of Coelus LLC where he facilitates full phase development of pharmaceutical IP and provides consulting About the Presenter About the Presenter services in toxicology, pharmacology, and AAHP President Mark Land is also V.P. of As Boiron’s regulatory affairs officer, Fanny Guillot hazard assessment. Dr. Reed is a pharmacolo- Government & Regulatory Affairs for Boiron has a global perspective of evaluating if products gist, board certified toxicologist, ABT Board USA, where he has worked in the homeopathic Regulatory Track Leader in a wide variety of therapeutic categories meet Member, and Fellow-Academy of Toxicology pharmaceutical industry for 39 years. He volun- Ann M. Begley Sciences (ATS). He has more than 25 years’ regulatory requirements for distribution in more teers as the Chairman of the Monograph Review Partner, Morgan, Lewis & Bockius LLP than 50 countries. Specializing in regulatory experience having Committee for HPUS. His expertise is in legal requirements throughout successfully and regulatory issues, www.MorganLewis.com the life cycle of health transitioned manufacturing, Based in Washington D.C., Ann Begley advises clients on FDA and FTC legal and regulatory issues products, multiple R&D quality control and relating to drug, cosmetic, dietary supplement, food, and medical device products — specializing in Fanny joined the programs through distribution of OTC drugs and clinical research matters. She has represented many clients in connection with FDA and global headquar- regulatory homeopathic FTC enforcement actions/inquiries, as well as competitor challenges before the Better Business ters of registration products. Bureau’s National Advertising Division. Boiron two milestones. years ago. AAHP_Program_11x17_Final6:Layout 1 6/25/19 2:37 PM Page 11