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Innovation & Compliance

Innovation & Compliance
by james.runkle@drummondst.com

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Innovation & Compliance: Essential Elements of Cosmetic Regulation, Safety Assessment, and Quality Assurance

May 8, 2019 (10:00am-1:00pm)

Javits – Level 1 Meeting Rooms

Jay Ansell – Vice President, Cosmetic Programs – Personal Care Products Council

Track Overview

Innovation is the at the heart of the personal care products industry and delivering innovative, safe and high-quality cosmetics the highest priority. Yet, in many instances, companies have to rely on third party experts to help to assure their products meet regulatory, safety and quality requirements. This session will highlight these fundamentals requirements for the non-expert to facilitate their understanding of the essential elements in assuring the successful development and marketing of personal care products.

Schedule

US Cosmetics Regulation

Jay Ansell – Vice President, Cosmetic Programs – Personal Care Products Council

10:00AM – 10:30AM

This session will provide an understanding of the legal and regulatory framework governing the marketing of cosmetics in the US including the responsibilities of both industry and the government.

International Nomenclature of Cosmetic Ingredients

Joanne Nikitakis – Director, Cosmetic Chemistry – Personal Care Products Council

10:30AM – 11:00AM

A key element in the launch of ingredients and cosmetic product labeling, the entire INCI process from application to published monograph will be explained.

Cosmetic Safety
Lambros Kromidas – Vice President and Regulatory Team Leader – Shiseido
11:00AM – 11:30AM

The law requires that every cosmetic and personal care product and its ingredients be substantiated for safety before going to market. This session will examine what type of data should be available on ingredients, how to evaluate the safety of finished products and what resources are available to help you substantiate safety.

Networking Opportunity

11:30AM – 12:00PM

Quality

Cathleen Owen – Director, Pharmaceutical & Personal Care Services – Q Labs

12:00PM – 12:30PM

While not required by law in the US, having an effective Good Manufacturing Practices (GMPs) program in place is critical in ensuring that products are consistently manufactured to a quality appropriate to their intended use. This talk will discuss how GMPs are implemented across your entire supply chain.

Panel Discussion

Birgit Huber – Deputy Director General – The German Cosmetic, Toiletry, Perfumery and Detergent Association


12:30PM – 1:00PM

The session will conclude with a moderated panel discussion with the speakers giving the participants a chance for an open dialogue with the experts.

Presenter Details

Joanne Nikitakis is a member of the science team at the Personal Care Products Council as the Director of Cosmetic Chemistry.  In her role, she serves as the staff liaison for the Council’s Quality Assurance Committee and International Cosmetic Ingredient Nomenclature Committee, and provides technical support for activities associated with these Committees. For more than 25 years, Joanne has been involved with the development of the INCI nomenclature program and publication of the International Cosmetic Ingredient Dictionary and Handbook in which she serves as principal editor. Joanne has also served as editor of the Council’s Quality Assurance Guidelines, and the Compendium of Cosmetic Ingredient Composition.

Ms. Nikitakis received her B.S. degree in Chemistry from the University of Mary Washington in Fredericksburg, Virginia, and M.S. in Pharmaceutical Sciences from the University of Cincinnati, College of Pharmacy in Cincinnati, Ohio.

Cathleen Owen has extensive experience in the pharmaceutical, cosmetic, and beauty care industries having spent time at Merck, Elizabeth Arden, Barr Laboratories, and KDC (Tri Tech Labs, Inc.), where she most recently served as Sr. Director of Quality and Regulatory Affairs. Cathleen will oversee Q Laboratories’ Quality Assurance Unit (QAU) maintaining accreditations and certifications, including ISO 17025 and cGMPs, as well supervising internal audits and facilitating external audits. She holds a B.S. in Chemistry from North Carolina State University and is currently Chair of the Quality Assurance Committee for the Personal Care Products Council (PCPC).

Birgit Huber studied food-technology in Stuttgart-Hohenheim. Since 1985 she has worked for IKW (The German Cosmetic, Toiletry, Perfumery and Detergent Association). She started as a scientific assistant, and then became Head of the Department of Cosmetics, Toiletries, Perfumes and Hygiene Paper Products in 1989. In June 2005 she was named Deputy Director of IKW. She is a member in different scientific and technical working groups in Germany and Europe, including the German Cosmetics Commission at BfR (Federal Institute for Risk Assessment) and the Board of GEPA (non-profit making association which supports the Information Network of Departments of Dermatology for the surveillance and scientific evaluation of contact allergies), Cosmetics Europe. She has given many presentations on international events on cosmetics and has published in English and German magazines. In 1987, Birgit Huber received the Maison de Navarre-Award of the IFSCC (International Federation of the Society of Cosmetic Chemists) in Santiago de Chile.

Dr. Lambros Kromidas holds a B.A. degree in the Biological Sciences and Classical Civilization from New York University. He received his M.S. and Ph.D. degrees in Biological Sciences from St. John’s University, Jamaica, NY, where he trained in Immunology, Microbiology, Toxicology and Electron Microscopy. He also held a Post-doctorate position at Cornell University Medical College, Department of Physiology, New York, NY. Before joining the Cosmetic Industry Dr. Kromidas’ held positions as an Adjunct Assistant Professor at St. John’s University’s College of Pharmacy and Allied Health Professions, Jamaica, NY and as a Research Scientist in the U.S. Department of Energy, Environmental Measurements Laboratory (currently part of the US Department of Homeland Security), New York, NY.

Dr. Kromidas’ Cosmetic Industry experience begun in 1996, when he joined Avon Products Inc. Subsequently he held positions at Coty Inc., La Prairie Inc. (Beiersdorf AG), and RIFM (Research Institute for Fragrance Material). Currently he is a V.P. at Shiseido Americas Corp. Dr. Kromidas is a highly accomplished and experienced R&D executive with consistent achievements in product safety, regulatory affairs, and product development support across multiple product categories worldwide.

Dr. Kromidas has numerous publications and has given various presentations on a variety of subject matter — from microscopy to toxicology to regulatory affairs. He is an active member of the Cosmetic Industry worldwide.

Jay Ansell, PhD joined the Personal Care Products Council (formerly CTFA) in May 2006 and is Vice President – Cosmetic Programs where he is responsible for providing technical support for the Council staff and various committees and task forces addressing the science and regulation of personal care products.

Dr. Ansell came to the Council from Yves Rocher, a France-based personal care products company, where he served as Director of North American Product Safety and Regulatory Affairs. He previously has been Vice President of Product Safety and Regulatory Affairs at two international specialty chemical companies.

Dr. Ansell has been an invited speaker on topics including safety and risk assessment. He was founder and president of the Council for Advance Agricultural Formulations, leads the Council’s nanotechnology activities, currently serves as Chairman and Administrator of the U.S. Technical Advisory Group to ISO Technical Committee 217 – Cosmetics, and is past President of the International Society of Regulatory Toxicology and Pharmacology.

Trained as a chemist, Dr. Ansell received his B.A. from Gettysburg College, Gettysburg, PA, and an M.S. from Marshall University in Huntington, WV. He completed his graduate studies at Binghamton University – the State University of New York where he was granted a PhD for his work on novel synthetic routes to bioactive materials and was first certified as a Diplomat of the American Board of Toxicology in 1986.

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