Industries: Pharma / BiotechSkin & Cosmetics

Global Personal Care Market & Regulatory Overview

Course Director: Wen Schroeder

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

Cosmetic products are ubiquitous in our daily life. Consumers are bombarded with newer and more attractive product offerings constantly. The cosmetic and toiletry industry continues to enjoy relatively good standing despite global recession. While traditional stronghold such as Western Europe, Japan, and the US appear to have been near their market saturation, the emerging markets such as Latin America and Asia have been roaring ahead with powerful growth. The former usually have established fairly sophisticated laws and regulations, while the latter tends to present more challenge as individual countries go through legislative evolution to integrate better into the global regulatory framework.

In general, to place a personal care product successfully in today's market requires more than superior formulation and attractive packaging. Despite years of international effort at harmonization, the cosmetic regulation has yet to arrive at a totally harmonized state, globally. A successful market entry strategy should take into consideration current market trend & demands, regulatory framework & compliance requirements, scientific findings in the performance, efficacy and safety of ingredients/products. This course will provide an overview of the global cosmetic legislative framework. Key focus is placed on comparing and contrasting cosmetic regulations in major world markets. Also discussed, is the corresponding C&T market outlook and consumer research specifics in each region.

Who Should Attend

This three-day course is designed for professionals in the personal care, cosmetic and pharmaceutical industries engaged in all aspects of cosmetic product development, including:

  • Research & Development
  • Technology, Formulation & Product Development
  • Marketing & Technical Sales
  • Regulatory Affairs
  • QA & QC Professionals
  • Business Decision Makers

First Day

Introductions & Agenda Review - 9:00am – 9:30am

Global Cosmetic & Toiletry Market - 9:30am - 11:00am

  • The consumers
  • The market
  • Future trend & outlook

International Cosmetic Regulatory Overview - 11:30am – 1:00pm

  • Global legislative fundamentals
  • Product definition & classification
  • Major regulatory camps
  • US/Canada
  • EU
  • Asia Pacific
  • Japan/East Asia
  • Australia/New Zealand
  • ASEAN
  • India
  • Latin America

Lunch - 1:00pm – 2:00pm

US Cosmetic Market & Regulation - 2:00pm – 5:00pm

  • US market specifics
  • Historical legislative development
  • Legal definition & distinction
  • Drug vs. Cosmetic
  • The myth of "cosmeceuticals"
  • Product classification standards
  • What about combination products?
  • Control of cosmetic ingredients
  • Manufacturing requirements
  • Cosmetic labeling
  • Cosmetic advertising & promotion
  • Post sale cosmetic products control
  • Import requirements
  • Process
  • Inspection
  • Permit, certification & labeling

Review, recap, questions & answers - 5:00pm - 5:30pm

Second Day

Workshop – US - 9:00am - 10:30am

  • Case studies - claims analysis
  • Group exercise - launch a new product in the US
  • Group exercise - import a foreign-made product into the US

Canada & Mexico Overview - 11:00am – 12:00am

Lunch - 12:00pm – 1:00pm

EU Cosmetic Market & Regulation - 1:00pm – 4:30pm

  • Legislative foundation
  • From the Directive to the Regulation
  • Scope & definition
  • Product classification standards
  • Control of cosmetic ingredients
  • Notification
  • safety & efficacy testing
  • Substances of concern
  • GMP requirements
  • PIF
  • Adverse event
  • Cosmetic labeling, advertising & claims substantiation
  • In-market control
  • Import requirements
  • Process
  • Inspection
  • Permit, certification & labeling
  • Controversial & emerging issues
  • Conflicting regulatory philosophy & requirements
  • Borderline products
  • Animal testing ban
  • Export of EU regulatory standards

Review, recap, questions & answers - 4:30pm - 5:00pm

Third Day

Workshop - 9:00am - 10:30am

  • Group exercise - launching a new product in EU
  • Group exercise - importing a foreign made product into EU

Japan/East Asia Cosmetic Market & Regulation - 11:00am – 01:00pm

  • Market analysis
  • Legislative comparison & contrast
  • Japan, Korea, Taiwan
  • Import requirements

Lunch - 1:00pm – 2:00pm

China Cosmetic Market & Regulation - 2:00pm – 3:30pm

  • Market analysis
  • Legislative basics & latest development
  • Import requirements
  • Emerging issues

Asia-Pacific Cosmetic Market & Regulation - 4:00pm – 4:45pm

  • Market analysis
  • Legislative comparison & contrast
  • Australia/New Zealand
  • ASEAN
  • India
  • Import requirements

Review, discussion, questions & answers - 4:45pm - 5:00pm

Course Evaluation - 5:00pm - 5:15pm

Learning Objectives

Upon completion of this course, the participants will be able to:

  • Describe global and regional C&T market
  • Describe global regulatory framework regulating cosmetic products
  • Outline the key difference between drugs and cosmetics based on appropriate product classification standards
  • Compare and contrast key cosmetic regulations in major markets
  • Describe specific import requirements and/or registration process for foreign-made cosmetic products and ingredients in various regional markets
  • Design and plan business strategies for successful manufacturing and launching of cosmetic products in various regional markets

Testimonials

"The Course Director is extremely experienced and brings a wealth of knowledge to the course. Appreciated her candidness across the 3 days. She was very good." Vicki H., Product Manager, Abbott
"The Course Director was amazing! Her vast amount of experience allowed her to give each of us in depth answers to any/all questions asked- and we had diverse backgrounds. It was an absolute pleasure to be in this course, and the small number of us gave the class a very cohesive feel." Kelly P., Senior Regulatory Affairs Specialist, GOJO Industries
"The Course Director was a fantastic instructor which made this course so much fun! The course material was relevant to business today." Leslie C., Senior Formulation Scientist, Rockline Industries