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WS1 - Duties, Responsibilities and Opportunities in the Cosmetic Regulatory Framework
Where: Mico, Blue Room 1 - When: Sept, 30th 10.30/13.30
An in-depth workshop consisting of expert’s speeches and fronctal lectures as an unique opportunity for cosmetics regulatory experts to be updated about latest European regulatory challenges and how to deal with the UK withdrawl.

Content and Objectives:
- Exploring the topics concerning the raw materials management according to the EFfCI GMP Certification Scheme Global.
- Discussing novel computational tools for human risk assessment of “data-poor” cosmetic ingredients.
- Analyzing future regulatory challenges for cosmetics, receiving an overview of the main changes plus an analysis of the controversial area of ‘claims’ including the currently referenced “free from” claim.
- Focusing on main duties and challenges about REACH vs COSMETIC Regulation, case history concerning the role of the Only Representative.

Worth for: R&D and Regulatory affairs experts.

Speakers:


I. Moore – Head of Global QA, Croda International plc After completing his doctorate studies in organometallic chemistry, he moved to Croda in 1987, where he has acted at the technical customer interface, leaded a team of chemists in the development of Croda’s products before holding various QA and project roles since 1995. He is current chair of the EFfCI GMP Guide for cosmetic ingredients.


A. Michelotti – Regulatory Affairs manager, Complife Italia S.r.l.
After her master’s degree in Biological Sciences, she is also SITOX-trained evaluator of cosmetic products safety in compliance with Cosmetic Regulation (EC) No 1223/2009.
Since 2003, she is head of clinical studies for assessing the safety and efficacy of cosmetic products and Regulatory affairs manager at Complife Italia S.r.l. She takes part in the EFfCI Regulatory Affairs and Product Safety working group (RAPS)”


A. Samuele – Specialist in Regulatory Affairs and Quality Assurance at Complife Italia S.r.l. (since 2012). Degree cum laude in Chemistry and Pharmaceutical Technology (1996). Unipro and SITOX-trained evaluator of cosmetic products safety in compliance with Cosmetic Regulation (EC) No 1223/2009. Qualified Internal Auditor according to UNI EN ISO 9001:2015 and ISO/IEC 17025:2017-Accredia requirements. 
Junior Researcher in Functional Neurochemistry and Molecular Genetics: 38 publications (total IF: 149.59) (2000-2012). 


S. Ferretti – Chief Compliance Officer & Public Affairs Director, Obelis S.A.
She is a Chief Compliance Officer with over 20 years of professional experience.
At Obelis S.A. she gained unique expertise in European regulatory affairs in the fields of cosmetics and medical devices. She specializes in the profession of Responsible Person and Authorised Representative.
She is very involved in ERPA and EAAR associations, and she advocates in various EU experts working groups: Standing committee on Cosmetics, CPNP, Claims, Cosmetovigilance, EUDAMED, and many others.


F.Gregorini – Chemicals Compliance Manager, Cepra S.r.l
Graduated at University of Bologna (Italy) in Chemistry and Pharmaceutical Technologies, now he is REACH – CLP contact person for local Chemist Society, member of EurChem – European Chemist, member of ERPA (European Responsible Person Association). He has strong expertise in Regulatory affairs, as consultant for EU and EXTRA EU companies, (REACH, GHS, Cosmetic) and in chemicals safety assessment.



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