Global Regulatory Summit 2014 speakers list

Cosmetics Business has released the program of speakers who will be part of this year's global Regulatory Summit held in Brussels, Belgium on 17-18 June

Details of the next conference from Cosmetics Business can be found here. For more information, or to be added to the mailing list, contact chrism@hpcimedia.com.


Cosmetics Business has released the program of speakers who will be part of this year's event.

The speakers will either be part of the roundtable debates and/or provide keynote presentations on the pressing issues faced within the cosmetics industry for regulatory compliance

The annual event sees the leading figures in the regulatory field of cosmetics present the recent issues faced worldwide for legislation compliance as it functions in reality. The summit looks to address how regulation affects the industry on a global scale and provides a platform for debate between various parties within cosmetics. The discussions that occur over the two day event will help to ensure that the future of regulation continues to bring practicality, feasibility and relevancy closer to its core.

Speakers:


1

Steven L. Hanft, M.A., President, CONUSBAT Internationalization Services

Topic: The reality of regulations: The hard work SMEs go through for compliance
- An insight into the practicalities of complying with the various safety regulations and the management of associated costs of such compliance
- Key criteria for compliance with REACH and the Cosmetic Products Regulation
- The EU’s SME definition and staffing in companies
- Cost implications from compliance steps – comparison of SMEs and Large Enterprises
- Gains from products compliance

As President of CONUSBAT, and with the mission to facilitate internationalization processes in companies, Steven L. Hanft provides regulatory and market development services to the global community. Located in North Rhine Westphalia, Germany, CONUSBAT focuses on REACH and cosmetics legislation; thus providing all services for compliance, e.g. OR, RP, products and substance safety assessments, etc. With the goal to enhance further transparency, CONUSBAT provides training on regulatory agencies & their internal frameworks such as the US-FDA & EPA, ECHA, etc.

Based on many years of professional experience in education and in industry in both the USA and Europe, Hanft is an expert and a dedicated trainer for CONUSBAT’s sector industries. Having founded the firm in 1996, he has served worldwide clients from the cosmetics, food & consumer health products, fine chemical production and life science industries as well as governmental organizations and academic institutions. Steven has been a faculty member of the HEC-Liege, the Technical & Teaching University Hospital RWTH-Aachen, has authored the book, “Fachenglisch für Laborberufe” (Technical English for Laboratory Personnel) for Wiley & Sons Publishing and was the co-organizer for In-Cosmetics Hamburg’s Animal Test Ban full-day workshop.

2

Professor Vera Rogiers, PhD Pharm, Head of the Department of Toxicology, Dermato-Cosmetology and Pharmacognosy, Vrije Universiteit Brussel

Topic: How safe is safe enough for market presence?
- An overview of what ‘safety’ means in bringing a product to market under the EU Regulation
- Providing an in-depth look into the various safety assessments that are available

Professor Vera Rogiers is Head of the Department of Toxicology, Dermato-Cosmetology and Pharmacognosy at the Vrije Universiteit Brussel. Her research team is specialised in the development of in vitro models for pharmaco-toxicological purposes as an alternative to the use of experimental animals in biotransformation and toxicity studies of drugs, cosmetics and other chemical substances.

Rogiers is author/co-author of 325 publications and is editor of several scientific books, including 69 book chapters. She has obtained several international scientific awards, in particular for her pioneer role in in vitro experimental toxicology. At the EU level, she has been for several years co-chair of the SCCS and is now invited expert. She is also advising DG SANCO in international harmonisation of safety assessment questions. She has been for several years member of ESAC. She is co-founder of ecopa (European Consensus Platform on 3R-Alternatives), bringing together Academia, Industry, Animal welfare and Governmental Institutes in the different EU Countries under a European umbrella, and served for 10 years as chair of this scientific association. She has coordinated 2 EU research projects (CONAM, Start-Up) and is research partner in 2 running FP7 EU projects concerned with in vitro methodology (Detective, HemiBio). Recently ended EU projects in which she was actively involved are Predictomics, Liintop, Esnats and carcinoGenomics. Besides involvement in several national projects(FWO and IWT), she is also coordinating inter-university research projects concerned with stem cell technology, including Hepro2 (IUAP project) and Brustem2(Innoviris project), and genotoxicity projects in collaboration with WIV(Wetenschappelijk Instituut Volksgezondheid).

3

Dr Jack Ferguson , Director, Skinnovation Ltd


Chairman at the roundtable debate discussing the following belief: “Sun protection labelling should be taken out of the laboratory and into consumer reality”
- A debate with industry experts with differing opinions on the matter
- A brief introduction by each speaker with their position on labelling and consumer awareness of how to interpret on pack sun-safety labelling as well as their view on the in vitro vs in vivo testing protocols that are currently used and for the future
- Chaired discussions about these pressing issues from all sides of the equation. Delegate participation and questions are encouraged and will be taken by the chairman.

Panellist on the roundtable debate discussing the following belief: “Testing protocols should favour multinationals rather than balancing the marketability of products across the board”
- A debate with industry experts with differing opinions on the matter from start-ups, SMEs, multinationals and independent bodies
- A brief introduction by each speaker with their position on testing protocol, regulatory compliance and whether ‘fairness’ and ‘balance’ is a valid argument
- Chaired discussions about these pressing issues from all side of the equation. Delegate participation and questions are encouraged and will be taken by the chairman.

Dr Jack Ferguson is an independent consultant to the cosmetics industry and is expert in sun care, skin care and support for advertising claims for cosmetic products.

Ferguson established the consulting company Skinnovation Ltd in the year 2000. The company provides bespoke formulation development services to cosmetic and pharmaceutical organisations for sun care and skin care products and is a cosmetic consultant to Clearcast, a body based in London which approves television advertisements prior to broadcasting and the Advertising Standards Authority (ASA). Prior to Skinnovation, he worked at senior levels in R&D at Beechams (London), Boots (Nottingham), and Oriflame (Dublin). Ferguson is the scientific programme organiser for the biennial London Sun Protection and Anti-Ageing Skin Care Conferences. He has participated in CTPA and Colipa technical committees and chaired the Colipa Task Force on sun protection measurement (1990 to 1998).

Ferguson is also a past president of the Society of Cosmetic Scientists (UK) and was the Scientific Programme Chairman for the 2002 IFSCC Congress in Edinburgh.

4

Debra Redbourn
, dR Cosmetic Regulations UK

Topic: Global supply: The notable areas in regulatory compliance
- When looking to release a product on a global scale, what are the notable areas in regulatory compliance of which a company and product developer must be aware?

Debra Redbourn is a consultant who advises companies on the EU Cosmetic Regulations and international cosmetic legislation. Since gaining her degree in Cosmetic Science she has gained 30 years’ experience working in the cosmetics industry, initially in the development of toiletries, skin care and colour cosmetics.

She has specialised in regulations since 1988 as Scientific Officer at the CTPA, the UK cosmetic trade association, which involved attending regular meetings in Brussels at Cosmetics Europe (then called Colipa).

In 1996, Redbourn set up her own cosmetic regulations consultancy advising a range of companies across the EU, Asia and America. This has included presenting at conferences and workshops and giving training, on the EU Cosmetics Directive/Regulation and international requirements. She has been the author of the legislation module of the SCS Distance Learning Diploma Course since it was set up.

5

Dr Annelie Struessmann, Technical Director, CONUSBAT Internationalization Services

Topic: Breaking into the Eurozone
- The EuroZone assures its internal market through regulatory frameworks issued for goods and services. When looking to introduce a cosmetic product into the EuroZone, awareness of the respective provisions has to be assured at all stages of product development and needs to be extended to the lifespan of the product in the market and even further on. Additionally, based on the EU’s regulatory processes special attentiveness is required for certain product and ingredient classes
- EU regulatory frameworks applicable to cosmetics
- Compliance specifics and potential pitfalls for non-EU manufacturers
- Including regulatory issues into the stages of product development
- Pre and post marketing compliance processes
- Products and ingredients with need for special awareness

Dr Annelie Struessmann is Technical Director with CONUSBAT, a provider of internationalisation services for the Fine Chemicals, Cosmetics & Life Sciences Industries. She joined the firm in 2003 and established the service area of regulatory affairs where she is focusing on the European regulatory frameworks for cosmetic products and for chemicals (REACH). The service spectrum includes dossier preparation, safety assessments, registrations, notifications and direct representations, etc. She has published numerous articles on these topics and provided workshops on a worldwide scale.

Struessmann was the co-organizer and ‘brains’ behind In-Cosmetics Hamburg Animal test Ban full day workshop. Before joining CONUSBAT, she worked in various managerial functions at international locations of global companies, such as IFF, Akzo Nobel, Rewo Chemicals (now Evonik). Her educational background includes a Masters Degree in Chemistry and a Doctorate in Biopolymer Chemistry.

6

Emily McIvor,
Policy Director of Humane Society International’s Research and Toxicology Department.

Topic: Animal testing: The push that's sweeping across the globe
- An overview on the different worldwide views on animal testing
- How such regulation impacts industry obligations of corporate responsibility
- The trade impacts of existing and future regulation and an analysis of the arguments against such bans

Emily McIvor is Policy Director of Humane Society International’s Research and Toxicology Department. McIvor has worked on EU animal welfare issues for many years, specialising in those concerning the use of animals in research and testing. She is also a member of the EPAA (European Partnership on Alternatives to Animal Testing) Mirror Group, a former Partner of the 7th Framework Programme project AXLR8 (www.axlr8.eu), and a member of the ECVAM Stakeholder Forum.

McIvor contributed to several processes during preparation and negotiation of Directive 2010/63 EU on the protection of animals used for research, and coordinated the ‘Make Animal Testing History’ campaign which focused on promoting measures to replace animals used in research and testing.

As a regular contributor to several REACH (Registration, Evaluation and Authorisation of Chemicals) committees and processes, and through HSI’s global ‘Be Cruelty Free’ campaign to end animal testing for cosmetics, McIvor continues to work for both immediate term reductions in animal use as well as the longer term goal of full replacement.

7

Ric Williams,
Contract Development Cosmetic/Cosmeceutical R&D Scientist, Cosmepeutics International.

Topic: Regulatory anomalies for the Asia Pacific region
- When looking to introduce a product to the Asian Pacific markets, what are the variations in regulatory compliance of which a company and product developer must be aware?

Educated in Sydney, Ric Williams obtained a Bachelor of Science in Pure and Applied Chemistry (University of NSW) and Diploma of Environmental Studies (Macquarie University). Ric has more than 40 years’ experience in the cosmetic/pharmaceutical industry working for local and international companies. He currently owns and operates the consultancy business, Cosmepeutics International, and is an Australian agent for AMA Laboratories Inc (USA).

Williams became a Member of the Australian Society of Cosmetic Chemists (ASCC) in 1982, served; as an ASCC Councilor for 14 years , the Technical Committee since 1984, the 1996 IFSCC Congress Organising Committee and represented ASCC on various government committees. In 2014 he was elected a “Fellow” of the Society for 30 years’ service.

Williams has presented many lectures and workshops at national conferences of the Australian Society of Cosmetic Chemists (ASCC); Association of Professional Aestheticians of Australia (APAA); Pharmacy Guild of Australia; Australasian Academy of Anti-Ageing Medicine (A5M); Cosmetic and Pharmaceutical Special Interest Group (CAPSIG) and beauty colleges Australia-wide. He has published a number of papers on the cosmetics industry, in the journals “Cosmetic Science in Australia”; “Science of Beauty” and “Personal Care Asia” and currently contributes a column (Formulator’s Forum) in “Science of Beauty”.

8

Jeffrey A. Quill,
Director of Technical Applications, Q-Lab Corporation USA.

Panellist on the roundtable debate discussing the following belief: “Testing protocols should favour multinationals rather than balancing the marketability of products across the board”
- A debate with industry experts with differing opinions on the matter from start-ups, SMEs, multinationals and independent bodies
- A brief introduction by each speaker with their position on testing protocol, regulatory compliance and whether ‘fairness’ and ‘balance’ is a valid argument
- Chaired discussions about these pressing issues from all side of the equation. Delegate participation and questions are encouraged and will be taken by the chairman.

Jeffrey A. Quill has been Q-Lab’s Director of Products and Applications since 2000.

He is a member of several ASTM, ISO and SAE committees dealing with standards for weathering and testing of coatings, plastics, printing inks, textiles and other materials. He is considered to be one of the world’s experts on light stability and weathering testing, and has given numerous presentations and seminars and authored many papers on the subject throughout the world.

Quill has a Bachelor of Science degree from Ohio State University.

9

Roman Mokry,
Policy Officer at the European Commission

Topic: Cosmetic product claims – European regulatory framework and common criteria
– An overview from the European Commission of the European regulatory framework and common criteria in cosmetic product claims

Roman Mokry is the Policy Officer at the European Commission in Brussels, a position he has held since 2005. In this role, he contributes to the formulation and implementation of the EU legislation in the area of cosmetics (Regulation (EU) No. 1223/2009) and medical devices (Directive 93/42/EEC). He also prepares and ensures quality (substance and presentation) and pertinence of legislative proposals – in particular directives on technical modifications, including impact assessment – and in regards to information exchange with national authorities and other stakeholders.

Before the European Commission, Mokry worked for L’Oréal as Category and Product Manager before becoming a consultant for Roedl&Partner in mergers and acquisitions for foreign companies looking to enter the Czech and Slovak markets. He is a CEMS Master in International Management and also has a Masters degree in International Trade and International Politics as well as being proficient in German, French, English, Spanish and his native tongue, Slovak.

10

Sandra Ferretti, Chief Compliance Officer at Obelis s.a.

Topic: The sticking points and resolutions from a regulator's perspective
- After nearly a year since its inception, the regulatory side of the industry discloses oft-reported problems and questions and provides some solutions to these areas.

With over 10 years experience in quality assurance and EU regulations, Sandra Ferretti as C.C.O. is responsible for overseeing and managing compliance issues within the organization and ensuring internal and client compliancy.

The responsibilities of her position include leading enterprise compliance efforts, designing and implementing internal controls, policies and procedures to assure compliance with applicable local laws, Member States, EU laws, EU regulations and third party guidelines, managing audits and investigations into regulatory and compliance issues, and responding to regulatory requests for information from clients and regulatory bodies.

11

Dr Marc Pissavini,
Director of the Basic & Applied Research at Coty-Lancaster Group

Panellist at the roundtable debate discussing the following belief: “Sun protection labelling should be taken out of the laboratory and into consumer reality”
- A debate with industry experts with differing opinions on the matter
- A brief introduction by each speaker with their position on labelling and consumer awareness of how to interpret on pack sun-safety labelling as well as their view on the in vitro vs in vivo testing protocols that are currently used and for the future
- Chaired discussions about these pressing issues from all sides of the equation. Delegate participation and questions are encouraged and will be taken by the chairman.

Dr Marc Pissavini is a chemist Ph.D and started his career in the cosmetic industry in the field of Analytical chemistry in 1997. Quickly (1998), he joined the Sun Research Department of Coty-Lancaster Group. Since 2008 he’s been the Director of the Basic & Applied Research, specialised in in vitro spectroscopy and in the study of the roughness of supports.

Pissavini contributes to the content of publications (22) and conferences (25). As an active participant in his field, he participates also at different task forces and at different groups of specialists for ANSM (AFSSAPS), AFNOR, or FEBEA for many years but also as Chairman in the in vitro Task force for Cosmetics Europe. Pissavini has also worked for ISO in the SPF in vitro group since 2012.

12

Claudia de Lucca Mano,
Practicing Attorney and Consultant, De Lucca Mano

Topic: Breaking into the Brazilian market
- An overview on existing regulatory frameworks for cosmetics products and ingredients covering: company licensing, concepts and basic guidelines for cosmetics, classification: degree of risk, clearance procedure within ANVISA: notification or registration, ingredients listings (Mercosur), labelling, new sunscreen regulation(Mercosur) and advertising.

With a law office in São Paulo, Brazil, since 1994, Claudia de Lucca Mano is a practicing attorney and consultant, who specialises on Brazilian regulatory affairs affecting health, pharmaceuticals, cosmetics, nutrition and medical devices. She is registered with the São Paulo Brazilian Bar branch, and has a law degree from Pontificia Universidade Católica, Sao Paulo, with emphasis on Collective Rights.

De Lucca Mano is the author of a regulation column for “A FORMULA©” (Consulfarma), a magazine specialised on pharmaceutical issues. She is an expert on Brazil’s National Agency for Sanitary Surveillance (ANVISA), also a member of Committee of Regulated Markets and Sanitary Law of Brazilian Bar, and of the American Bar Association, Section of International Law, Committees of Foreign Legal Consultant and International Life Sciences and Health Law.

13

Ellen Pfrommer,
Head of Product Stewardship & EHS Master Data Personal Care, BASF

Topic: Regulatory compliance and more… Consequences for cosmetic ingredients
- Legal Requirements, including why some ingredients are being restricted and what can trigger a ban
- Legal Obligations and Responsible Care of ingredient manufacturers
- The impact of animal testing ban and marketing ban
- The challenges to get to innovative ingredients

Ellen Pfrommer has been with BASF for more than 20 years. Today, she has the responsibility at BASF for Product Stewardship & EHS Master Data for Personal Care Ingredients.

Pfrommer graduated from the University of Karlsruhe (Germany) with MS in Food Chemistry, which is a special branch of chemistry with focus on analytics and regulations. After graduation she joined BASF and started her career in application work for colorants for use in food, pharma and cosmetics. Later on she focused on cosmetic ingredients at BASF and stayed in this area, holding various positions throughout the years: Technical Product Management, Development, Technical Service and Global Key Account Management. Before taking over the responsibility of the Product Stewardship unit she was responsible for the Technical Service in Europe.

14

Alan Ritchie,
Regulatory Services Manager, Caleb Management Services Ltd

Topic: How and why some ingredients are banned: does ‘due diligence’ have a limit?
- An overview of how the REACH initiative impacts due diligence of industry when developing and selling cosmetic products
- The talk will look to cover generic safety and regulatory issues with ingredients such as compounds of arsenic, lead, mercury, pesticides etc.; environmental issues; cosmetics-specific safety concerns, which can result in either prohibition or restriction
- Substances prohibited because they have a known pharmacological effect and substances that have been on the Cosmetics Regulation under a positive listing but have dropped off the list and are now consequently prohibited will be discussed with reasons as to why this can happen
- Finally, the commercial, regulatory and media consequences of a substance being banned as well as the impact of media attention on a substance will be highlighted in order to fully understand the repercussions of facilitating the 'due diligence' mantra to varying extents.

Alan Ritchie is Regulatory Services Manager for Caleb Management Services Limited, which he joined in June 2007. Prior to this, he has been Head of Technical Services for Revlon, Regulatory Affairs Manager for Crompton (now Chemtura), and Product Stewardship Manager for ISP (nowpart of Ashland Chemicals). He has worked in the area of chemicals control regulations (includingREACH) for 18 years. During this time, he has represented his employers’ organisations onvarious trade groups, including 2 CTPA committees (Scientific advisory group and advertising standards working group), Additives Technical Committee (ATC), WTR (rubber chemicals), and the UK Chemical Industry Association Chemical Policy Task Force. A graduate chemist from Stirling University, he began his career in R&D with Cadbury Schweppes before joining ISP to take responsibility for QA and later regulatory affairs.

15

Catherine Renard,
Senior Financial Executive, Quatre S Cosmetics

Topic: Living with the Regulation from a SME perspective
- This practical view point from an SME company provides an insight into the weight of the change from the Directive to Regulation and what they learned from their experience
- The issues today for SME companies within the EU are not technical ones to overcome but economical ones
- Interpretation of the EU regulation with various languages barriers has a costly impact on packaging and time consuming completion of PIFs
- Understanding the role and responsibilities between the importer and the ‘responsible person’.

Catherine Renard, PhD, MBA, has worked for several years as a researcher in the biotech field and has discovered new cosmetics applications from agricultural materials. A former member of the French cosmetologic commission for the French Ministry, in 2003 Renard set up Quatre S Cosmetics to help niche cosmetics brands secure distribution in France and in the EU, in partnership with her associate Emmanuel Teste.

16

Sharon A. Blinkoff,
Counsel, Edwards Wildman Palmer LLP

Topic: Regulatory anomalies in the fragmented US market
- When looking to bring a product to the US Market what are the variations in regulatory compliance of which a company and product developer must be aware with specific focus on regional state activity with particular emphasis on California and Prop 65 and the Class action litigation

Sharon A. Blinkoff represents manufacturers, marketers, and distributors of cosmetics, dietary supplements, over the counter drugs, and medical devices as well as beauty appliances and other consumer products and luxury goods. She regularly advises clients on compliance with the laws enforced by the FDA, CPSC, and the FTC, and obtaining FDA registrations and 510k premarket clearances.

Having served as Division and Regulatory Counsel for Bristol-Myers Squibb as well as Senior Counsel for Revlon, Blinkoff brings considerable experience in representing regulated businesses on a broad range of regulatory and business matters. Ms. Blinkoff also served as General Counsel to Ethan Allen Inc. and was part of the management group that restructured the company and took it public. With her broad regulatory experience and business background, Blinkoff brings considerable knowledge and expertise to the challenges faced by her clients. Having spent her early career as a patent attorney for the National Institutes of Health, she also brings a keen understanding of the technical side of the regulatory process and the interplay between regulatory issues and IP assets and how they relate to the client’s business strategy.

Blinkoff has successfully defended clients in regulatory proceedings before the FDA and the FTC, and has instituted and defended clients in advertising challenges before the NAD, ERSP and the FTC as well as in Lanham Act litigations. She has also assisted in the structuring business transactions involving regulated products and industries, including corporate acquisitions and divestitures, public offerings, joint venture and distribution agreements.

17

Dr Florian Schellauf,
Issue Manager, Technical Regulatory Affairs, Cosmetics Europe

Topic: The future of cosmetics regulation
- Cosmetics Europe will present their interpretation of regulation in the future and how this would impact compliance

Dr. Florian Schellauf was born in Graz (Austria) in 1971. He studied technical chemistry at the Technische Universität Graz. After finishing his doctoral studies in 2000, in which he specialized in Biotechnology, he was working at the Università di Pisa.

Several research projects on such varied topics as Biopolymer Technology and BSE-related issues followed, before he joined Colipa for a traineeship in July 2001. After two months as a trainee at the European Commission DG Enterprise Unit F3 (Cosmetics), he became employed in January 2002 at Colipa as Scientific Assistant and later as Issue Manager, Science & Research. He is currently holding the position of Issue Manager, Technical Regulatory Affairs at Cosmetics Europe (formerly Colipa). His responsibilities within Cosmetics Europe are ingredient issues related to human health and implementation of the Cosmetics Regulation (hair dyes, nanomaterials, fragrance ingredients…).

18

Professor Philippe Masson,
Chairman, EVIC International Group and Manager, EVIC France Laboratories

Topic: The globalisation of markets: How to comply
- With the space and time between locations becoming smaller as communications and technology increase worldwide, it continues to get easier to sell products to the far corners of the world; but when a product is made in one country and sold in or bought online from a variety of locations, at which point do the various global regulations become relevant for the product?
- Is regulatory harmonisation likely to occur in the foreseeable future?

Professor Philippe Masson graduated from the Medical School and Sciences University of Paris and has since then go on to become Chairman of the EVIC International Group and Manager of EVIC France Laboratories, a Research and Experimental unit created and chaired since 1969, where his current efforts lie.

In between these two milestones, Masson has been a regular professor in Toxicology and Experimental Cosmetology at the Institut de Pharmacie Industrielle of Bordeaux and Lyon, and in Toxicology and Cosmetology at the Free University of Brussels-ULB. He has also been associate professor in Toxicology at Vrije Universiteit in Brussels and the University of São Paulo.

Masson has been a scientific expert and consultant with a number of worldwide National Authorities in the chemical, cosmetic and pharmaceutical industries over the years as well as contributing to 12 books, and being the main author of 46 publications, 28 posters and more than 200 presentations.

In regards to national and international associations, Masson has covered the roles of Chairman of the CEN TC392 in charge of standardisation process in the cosmetic area, Chairman of the ISO TC217/WG7 in charge of Sun Protection Cosmetic Product, Chairman of the French CT S92J " Biological Assessment of Medical Devices” and CT S91K “Cosmetic Products", and a former member of the Scientific Committee on Consumer Products (SCCNFP) - DG Sanco - European Commission.


Sponsor: AMA Laboratories Inc.

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