Event Calendar

15 November 2016

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

(73777)
  • Compliance with the European Cosmetics Products Regulation (EC) 1223-2009
    Compliance with the European Cosmetics Products Regulation (EC) 1223-2009 Compliance with the European Cosmetics Products Regulation (EC) 1223-2009

Venue: 

Online Event

Date: 

15 November 2016

Time: 

10:00 AM - 11:30 AM

Phone: 

+971-8003851607

Website: 

http://www.mentorhealth.com/control/w_product/~product_id=800868LIVE?channel=mailer&camp=Webinar&AdGroup=dayofdubai_NOV_2016_SEO

Address: 

Online Event , NetZealous LLC-MentorHealth, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA
Fremont,CA 94539, USA
94539 Sharjah

Description: 

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. In-market control is assigned to EU Member State competent authorities. The flow of information between countries is interlinked by the Cosmetic Product Notification Portal (CPNP), which is fed with the information by the demand for pre-market notification of cosmetic products and by ongoing cosmetovigilance procedures put in place with the respective provisions in the CPR. The central role in cosmetovigilance applies to the Responsible Person while the access to manufacturers and responsible persons is assured by product labeling provisions.

During the workshop the provisions depicted as regulatory modules will be presented and explained. On the basis of the knowledge gained from this introduction, alleys towards compliance will be depicted which will use practical examples and experiences made while having performed the necessary compliance steps before marketing of cosmetics products in the European Union.

Why should you attend:

The European Cosmetics Products Regulation (EC) 1223/2009 (CPR) represents a newly recasted piece of legislation, fully implemented since July 2013, and putting in place demanding provisions for those seeking compliance. Affected by the challenges of meeting compliance are the players in the world's biggest cosmetic market, the European Union's internal market, as such similarly EU and non-EU manufactures of cosmetics as well as the suppliers of cosmetic ingredients requested to provide data on their chemicals.

Provisions of the CPR are formulated as modules and these include substance regulations, product information file, labeling, cosmetovigilance, claims, notification, responsible person, etc. Compliance with these modules requires know-how, diligence and ongoing adjustment to state of the art of knowledge and documentation. In this format, the EU Regulation represents not only the entry requirements for marketing of cosmetic product in the European Union; however, it represents as well a model framework for many national legislators worldwide. These legislators often either adopt certain of the modules or the structure of the Regulation in full, respectively of its predecessor legislation, the Cosmetics Directive. Therefore, skills to comply with the EU's CPR support and supply a background for attempting compliance with other regulatory frameworks.

The seemingly hardest module of the CPR is the safety assessment, requiring extensive skills in various science areas, such as toxicology, chemistry, cosmetology, microbiology, etc., as well as the knowledge in regulatory affairs and compliance management. Further difficulties with the EU's legal provisions arose from the final implementation of the animal testing ban in March 2013. In consequence, sometimes contradictory requirements arise from different sector legislation or from the requests in various legislative areas worldwide prior to marketing. Additionally, validated alternative tests are not available for all toxicological endpoints required to be assessed within the safety assessment and the Cosmetic Product Safety Report. Therefore, manufacturers are placed in an extremely complicated regulatory and scientific environment for meeting the compliance needs in general and especially for introducing new ingredients.

Areas Covered in the Session:

Animal Testing Ban
Roles & Responsibilities in the Supply Chain
Product Information File (PIF)
Safety Assessment
Criteria for Claims
Cosmetovigilence
Substance Regulations
Product Labeling
Borderline Legislation

Who Will Benefit:

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

Speaker Profile :

Dr. Annelie Struessmann is Technical Director with CONUSBAT, a provider of internationalization services for the Fine Chemicals, Cosmetics & Life Sciences Industries: www.conusbat.com. 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. Before joining CONUSBAT, Dr. Struesmann 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.

Price : $139.00

Contact Info:
MentorHealth
Phone No: 1-800-385-1607
FaX: 302-288-6884
support@mentorhealth.com
Event Link: http://www.mentorhealth.com/control/w_product/~product_id=800868LIVE?cha...
http://www.mentorhealth.com/

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Fundraising Under HIPAA: What You Need to Know, What You Need to Do 2016

(73776)
  • Fundraising Under HIPAA: What You Need to Know, What You Need to Do 2016
    Fundraising Under HIPAA: What You Need to Know, What You Need to Do 2016 Fundraising Under HIPAA: What You Need to Know, What You Need to Do 2016

Venue: 

Online Event

Date: 

15 November 2016

Time: 

10:00 AM - 11:00 AM

Phone: 

+971-8003851607

Website: 

http://www.mentorhealth.com/control/w_product/~product_id=800867LIVE?channel=mailer&camp=Webinar&AdGroup=dayofdubai_NOV_2016_SEO

Address: 

Online Event , NetZealous LLC-MentorHealth, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA
Fremont,CA 94539, USA
94539 Sharjah

Description: 

Overview:

In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising.

The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates.

The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations.

The "magic words" mandated by HIPPA-related regulations changed in multiple areas. The webinar will cover all of these areas to ensure your organization is both legally compliant and operationally effective.

The types of information that may be used for fund raising changed significantly. This presents numerous substantial fund raising opportunities, as well as challenges on the use and storage of such information.

Among other areas to be presented are

The required method for individuals to opt-out of receiving fund raising communication
The methods of informing patients and clients of their right to opt-out from receiving fund raising communication
The broadly expanded types of fund raising communication subject to opt-out rights
How providers, hospital, and related fund raising foundation apply an opt-out election by an individual
The type of patient and client information that health charities may use for fund raising
The contents of provider's Notice of Privacy Practice
How clinicians can assist both their patients/clients and the health organizations with which they are affiliated when it comes to fund raising

Why should you attend:

Institutions that fundraise and have access to of HIPAA protected health information need to be aware of opportunities to hone fund raising strategies to maximize philanthropic revenue for your organization.
If your organization uses telephone or e-mail solicitations, you will learn how new specific provisions of HIPAA now govern your fund raising activity, and effective policies to implement these rules.
Similarly, health related institutions that fund raise must make sure their fundraising practices minimize the compliance risks and satisfy mandates governing the use of patient/client information.
If you are a health care professional who is affiliated with a fund raising institution, you will learn how you can remain both ethically and legally complaint with patient privacy, which assisting both your affiliated institution and your patient/client.
Institutions will learn about compliance requirements for donor data base management. You will also learn effective and efficient strategies to maintain compliance.
You will learn how to keep your fund raising communication and related policies compliant without impairing operational effectiveness.

Areas Covered in the Session:

New types PHI that may be used for fund raising
New requirements for Notice of Privacy Practices
New requirements for protocols to allow patients to opt-out of using their PHI for fund raising

Who Will Benefit:

CDO and Other Development Staff
CDO and IT Compliance Staff
General Counsel and General Compliance Staff
Physician Leaders (CMO, Department Chiefs, Division Heads)
CNO and Clinical Leaders
Administrative Department Heads

Speaker Profile:

Joel Simon is one of the nation’s leading experts on the fund raising aspects of HIPAA. Joel has been a member of the Maryland bar for more than 25 years, and his professional experience includes work as the assistant in-house counsel at a community teaching hospital. Joel is an editor of “Fundraising Under HIPAA” published by the Association of Healthcare Philanthropy. He has lectured frequently on fund raising under HIPAA to national audiences since the original HIPAA regulations were first proposed more than 12 years ago.

Price : $139.00

Contact Info:
MentorHealth
Phone No: 1-800-385-1607
FaX: 302-288-6884
support@mentorhealth.com
Event Link: http://www.mentorhealth.com/control/w_product/~product_id=800867LIVE?cha...
http://www.mentorhealth.com/

LinkedIn Follow us – https://www.linkedin.com/company/mentorhealth
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