seminars

2-day In-person Seminar :

Compliance with the European Cosmetics Products Regulation (EC) 1223/2009

Annelie Struessmann
February 5th & 6th, 2015

Register for Seminar

San Diego, CA

For discounts on multiple registrations, contact customer care at

+1-800-921-1537

February 12th & 13th, 2015

Miami, FL

About GCPseminars:
GCPseminars is a training source that delivers diverse, high quality regulatory & compliance trainings. These
trainings are simple while being relevant and cost-effective while being convenient. GCPseminars imparts
knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars,
conferences and tailored, individualized consulting. These help organizations and professionals implement
compliance programs that meet regulatory demands and put business processes in place. Through our trainings,
we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn
or be aware of those regulations, on the other.Our services benefit the Medical Devices, Pharmaceutical, Bio
Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes
companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune
500 companies. Professionals who undergo trainings from GCPseminars exhibit a vastly improved quality of life in
which there is increased productivity and professional growth. Some 30,000 professionals have gained from more
than 500 training courses we have conducted till now

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Overview:
Since July 2013, Regulation (EC) No 1223/2009 on Cosmetic Products of the EU has been fully implemented and
represents a modern regulatory framework grounded on state of the art of cosmetic science and product technology. It is structured in regulatory modules, which include the safety assessment and the Cosmetic Product Safety
Report (CPSR), Product Information File (PIF), Responsible Person (RP), label information, cosmetovigilance,
substance regulations, claims, etc. The legislator's existing goal is assurance of the safety for the ingredients and
for the cosmetics products in use of consumers.

Agenda:
Day 1:

Day 2:

Lecture 1: Regulation (EC) 1223/2009 - Cosmetics

Lecture 1: Safety Assessment

Product Regulation

Requirements for the Product Safety Assessment

The Recast and its Legislative Environment

PART A - Cosmetic product safety information

Main Drivers for the Amendment

PART B - Cosmetic product safety assessment

Key Outcome - Areas of new contents & provisions

Lecture 2: The Animal Testing Ban

Stages of implementation in Europe

Progress in development of alternative non-animal

How to approach a safety assessment

to Annex I

Intrinsic information requirements for cosmetic ingredients

Toxicological prole for ingredients & cosmetic products,

methods

sources & data evaluation

Challenges arising for the industry from the testing &

marketing bans

Criteria for trace contents, microbiology, exposure

Information going into the weight-of-evidence approach

- data generated from other regulatory processes

Lecture 3: Roles & Responsibilities in the Supply

Chain

The SCCP's notes for Guidance & Commission Guidance

Lecture 2: Criteria for Claims

Article 40: Claims & process towards determining claim

The Actors in the Supply Chain - Denitions

Allocation of Responsibility for Product Safety

The Responsible Person - Obligations of the

Regulation (EU) No 655/2013 on criteria for claims

Responsible Person

Claims criteria - horizontal legislation

Specic Distributor Obligations

criteria

Lecture 3: Substance Regulations

Cosmetics Annexes - Inclusion processes

Content, format, language

Nanomaterials

Interaction with competent authorities

CMRs

Maintenance

Hair Colorants

Lecture 4: Product Information File (PIF)

Lecture 5: Cosmetovigilence

Lecture 4: Product Labeling

Serious undesirable events - denition & reporting

Requirements from the Cosmetic Product legislation

PIF Documentation

Other applicable EU legislation

Access to information for the public

Lecture 5: Borderline Legislation

Medicinal Products
Biocides
General Product Safet

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Pricing List

GROUP REGISTRATIONS

Price for One Delegate pass Price: $1,295.00

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5 Attendees

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3 to 6 Attendees - Get 20% off

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7 to 10 Attendees - Get 25% Off

10+ Attendees

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**Please note the registration will be closed 2 days (48 Hours)

prior to the date of the seminar.

What you get

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2. Participation certificates
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6. Special price on future consulting or expertise

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7. Special price on future seminars by GCPseminars.

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Look forward to meeting you at
the seminar
Team GCPseminars

NetZealous LLC, DBA GCPseminars

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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