רישום תמרוקים בארץ ובאירופה

החקיקה הישראלית שמאמצת את החקיקה האירופאית – השווה והשונה

תאריך: 16, 17 פברואר 2016
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 3,500 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 16686
שפת הקורס: אנגלית
על הקורס
לאחרונה, נתנו המחוקקים ברחבי העולם את דעתם להסדרה של ייצור, שיווק והפצה של תמרוקים.
בקהילה האירופאית, יושמה (וממשיכת להיות מיושמת) תקנה (EC1223/2009) שעוסקת במוצרים קוסמטיים ומחייבת את היצרנים והמשווקים באופן מלא מאז יולי 2013. עמידה בדרישות אלה הינה חובה בארצות הקהילה והיא מהווה מסגרת רגולטורית, שנסמכת על ידע מדעי מבוסס ועדכני וניסיון רב שנרכש בפיתוח מוצרים קוסמטיים.
התקנה מורכבת ממספר מודולים, לדוגמה, הערכת בטיחות, Responsible Person - RP, תיווי, cosmetovigilance ועוד. היא מהווה מודל לחיקוי עבור מחוקקים בעולם, שאימצו את עיקריה במלואם או בחלקם. גם בישראל אומצו העקרונות האירופאיים כפי שניתן להיווכח בתקנות הרוקחים (קוסמטיקה) 2012-5773.
הסדנה מתמקדת במודולים הרגולטורים של התקינה האירופית, מתארת את הוראותיהן המפורשות ומדגימה כיצד לענות להן. באמצעות מבוא לשתי מסגרות רגולטוריות אלה (האירופית והישראלית) נמתח קווי דמיון ושוני. הסדנה מתמקדת בדמיון בין המודולות ומציגה דוגמאות מעשיות של רישום מוצרים קוסמטיים באיחוד האירופי בהתאם לדרישות תקנה 1223/2009.
קהל היעד

Members of:

  • Cosmetics, personal care and consumer health product industries
  • Ingredient suppliers, fine chemicals companies
  • Regulatory affairs
  • R&D, product formulation
  • Marketing, product management
  • International sales, export
  • Government officials, KOLs
רישום תמרוקים בארץ ובאירופה
התועלת שתופק

The workshop introduces the EU’s regulatory modules and relates these to the new Israeli law. The specific provisions for each module will be depicted and ways of proceeding towards meeting compliance will be demonstrated to the participants. A key value will be laying in joining in practical experiences made, especially during the implementation phases of the Regulation between 2009 and 2013, and as such gaining stimulation and guidance on how to address the new Israeli law.

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

 

DAY 1

Welcome & Introduction
Yehudith Wexler
Bioforum
09.00 – 09.45 Part 1: The Pharmacists’ Regulations (Cosmetics) 2011-5772
  • Draft proposal by Binyamin Netanyahu, Prime Minister and Health Minister, Israel 2011 – An Overview
Rinat Bachar
Israeli Ministry of Health (MOH),
Cosmetics Department
09.45 – 10.30 Part 2: Amending Existing Legislation: Regulation (EC) 1223/2009
  • Cosmetics Product Regulation
  • The Recast and its Legislative Environment
  • Main Drivers for the Amendment
  • Key Outcome - Areas of new contents & provisions
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
10.30 – 10.45 Q&A / Discussion
10.45 – 11.00 Coffee Break
11.00 – 12.00

Part 3: Analysis on Similarities and Differences for the two Regulatory Frameworks

  • [Notice of Importation, Definition: Manager (granting according to Regulation 8), Recognized Country, General Cosmetics License, Suitable Cosmetics’ Storage and Transport Conditions, Certificate of Free Sale in the country from which it is being imported, Microbial Quality, Notification, etc.]
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
12.00 – 12.30

Part 4: Key Chapters of the EU Cosmetics Product Regulation – The Animal Testing Ban

  • Key drivers for the animal testing ban
  • Stages of implementation in Europe
  • Existing legal situation in Europe – worldwide comparison
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
12.30 – 13.30 Lunch Break
13.30 – 14.00

Part 5: Key Chapters of the EU Cosmetics Product Regulation – The Animal Testing Ban

  • Progress in development of alternative non-animal methods
  • Challenges arising for the industry from the testing & marketing bans
  • The future toolbox for toxicologists
  • Issues and opportunities for developing new cosmetic ingredients
  • Conflicts with other European legislation
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
14.00 – 14.30

Part 6: Key Chapters of the EU Cosmetics Product Regulation - Roles & Responsibilities in the Supply Chain

  • The Actors in the Supply Chain - Definitions
  • Allocation of Responsibility for Product Safety
  • The Responsible Person - Obligations of the Responsible Person
  • Specific Distributor Obligations
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
14.30 – 15.00

Part 7: Key Chapters of the EU Cosmetics Product Regulation - Product Information File (PIF)

  • Content, format, language
  • Interaction with competent authorities
  • Maintenance
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
15.00 – 15.15 Q&A / Discussion
15.15 – 15.30 Coffee Break
15.30 – 17.00

Part 8: Key Chapters of the EU Cosmetics Product Regulation - Safety Assessment

  • Requirements for the Product Safety Assessment
    • PART A – Cosmetic product safety information
    • PART B – Cosmetic product safety assessment
  • How to approach a safety assessment
    • The SCCP’s notes for Guidance & Commission Guidance to Annex I
    • Intrinsic information requirements for cosmetic ingredients
    • Toxicological profile for ingredients & cosmetic products, sources & data evaluation
    • Criteria for trace contents, microbiology, exposure
    • Information going into the weight-of-evidence approach - data generated from other regulatory processes
Dr. Annelie Struessmann
Technical Director
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
DAY 2
09.00 – 09.30 Part 1: Review and Q & A on Day 1
09.30 – 10.00

Part 2: The European Union

  • The Political Union
  • The European Union In the World
  • The Cosmetics Market and the Industry
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
10.00- 10.30

Part 3: The European Union’s Legal Authority and Approach to Industry Regulation

  • Basic Principles
  • Legal Tools
  • The legal process for the example of the Cosmetics Product Regulation
  • EU modules in world-wide regulations
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
10.30 – 11.00 Coffee Break & Discussions
11.00 – 11.45

Part 4: Key Chapters of the EU Cosmetics Product Regulation - Criteria for Claims

  • Article 40: Claims & process towards determining claim criteria
  • Regulation (EU) No 655/2013 on criteria for claims
  • Claims criteria – horizontal legislation
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
11.45 – 12.30

Part 5: Key Chapters of the EU Cosmetics Product Regulation - Cosmetovigilence

  • Serious undesirable events – definition & reporting
  • PIF Documentation
  • Access to information for the public

Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany

12.30 – 13.30 Lunch Break
13.30 – 14.15

Part 6: Key Chapters of the EU Cosmetics Product Regulation - Substance Regulations

  • Cosmetics Annexes – Inclusion processes
  • Nanomaterials
  • CMRs
  • Hair Colorants

Part 7: Key Chapters of the EU Cosmetics Product Regulation – Product Labelling

  • Requirements from the Cosmetic Product legislation
  • Other applicable EU legislation
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
15.00 – 15.15

Q&A / Discussion

15.15 – 15.30 Coffee Break
15.30 – 16.00

Part 8: Interfaces between the Cosmetics Product Regulation and EU legislation for chemicals - REACH

  • Requirements for cosmetic ingredients
  • Challenges from testing requirements
  • Classification and labeling of hazardous substances and mixtures
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
16.00 – 16.30

Part 9: Borderline Legislation

  • Medicinal Products
  • Biocides
  • General Product Safety
  • Worldwide Outlook
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
16.30 – 17.00

Part 10: Implementing regulatory affairs to the stages of product development

  • Pre- and post-marketing compliance processes
  • Regulatory environment applicable to cosmetics
  • Compliance specifics and potential pitfalls for non-EU manufacturers
  • Products and ingredients with need for special awareness
  • Supporting tools
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
אודות המרצה

Dr. Annelie Struessmann

Technical Director, CONUSBAT
Dr. Annelie Struessmann is Technical & Regulatory Director with CONUS Business, Advice & Training (CONUSBAT), and a provider of internationalization services for the Fine Chemicals, Cosmetics & Toiletries, Food and Pharmaceutical Industries: www.conusbat.com. In 2003, she joined the firm and, based on many years of experience gained while working with the international industry, she established the service area for regulatory affairs.
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Mr. Steven L. Hanft M.A

President, CONUSBAT
As President of CONUSBAT, and with its mission to facilitate internationalization processes in companies, Mr. 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
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גב' רינת בכר

Israel, MOH
מנהלת המחלקה לתמרוקים באגף הרוקחות של משרד הבריאות

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