BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 12.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VEVENT CLASS:PUBLIC CREATED:20100122T154811Z DESCRIPTION:Just a friendly reminder that dicentra’s online seminar on Su ccessful Product Submissions will take place this coming Wednesday. Visit www.dicentra.ca/training to register now.\n\nSuccessful Product Submission s: How to Register Your Multi Ingredient Products for Unique Health Claims \nWednesday\, February 24\, 2010\, 1:00 PM Eastern Time\n60 minutes follow ed by a 30 minute question and answer period\nAnne Wilkie\n1 Certificate o f Course Completion issued to the attendee\, and archive of the PowerPoint and audio to keep forever\n \n\ nAs of November of 2009 the Natural Health Products Directorate (NHPD) has completed 33\,000 of 43\,000 product license applications received. Out o f these 48% have either been withdrawn by the applicant (11%) or refused b y the NHPD (37%). Later this fall the NHPD is expected to make an announce ment on new enforcement measures with potential target dates as to when pr oducts will absolutely require a license before entering the marketplace.\ n\ndicentra’s 2010 Successful Product Submissions Web Seminar will addre ss the many challenges facing industry in obtaining Natural Product Number s and will provide potential solutions to overcome these challenges. This seminar is presented only once a year and is derived from dicentra’s exp erience in completing thousands of Product License Applications. Topics co vered include:\n* a summary of the recent NHPD workshops outlining complia nce and enforcement measures\;\n* an update on the status of submissions a t the NHPD\;\n* an overview of the product submission review process that takes place at the NHPD\;\n* a list and discussion of reasons why products are being refused\; and\,\n* what can be done to improve the likelihood t hat your product will be approved\, especially for non-traditional applica tions. \nThe seminar presenter\, Anne Wilkie\, is the former Vice Presiden t and Head of Regulatory Affairs for the Canadian Health Food Association\ , Canada's largest trade association representing the interests of retaile rs and suppliers of natural products and organics. Anne held this role for the past 10 years during which time she developed and led the regulatory program for the CHFA and was actively involved in the creation and impleme ntation of the Natural Health Products Regulations and consultations on th e Organic Products Regulations. Prior to the CHFA\, Anne worked for Health Canada and the Canadian Food Inspection Agency in a variety of roles incl uding Laboratory Analyst\, Food and Drug Inspector and Nutrition Program S pecialist.\n\nAnyone involved in preparing submissions for Product License Applications should attend this course to fully understand the review pro cess at the Natural Health Products Directorate and to acquire the ability to submit a complete and successful application.\n\n DTEND:20100526T183000Z DTSTAMP:20100122T154811Z DTSTART:20100526T170000Z LAST-MODIFIED:20100122T154811Z LOCATION:Online PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:Dicentra Online Seminar: Classification of Products at the Cosmetic-Drug Interface TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000010DB44D24F9BCA01000000000000000 010000000D9872C999A33A24583E9323AB602F9BA X-ALT-DESC;FMTTYPE=text/html:\n\n\n\n\n\n\n\n\n

Just a friendly reminder that dicentra’s online seminar Classification of Products at the Cosmetic-Drug Interface will take place this coming Wednesday. Visit www.dicentra.ca/ training to register now.

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Classification of Products at the Cosmetic-Drug Interface: a Deeper Look
\nWednesday\, May 26\, 2010\, 1:00 PM Eastern Time
\n 60 minutes fo llowed by a 30 minute question and answer period
\nWilliam Morkel &\; Clara Di Tella
\n1 Certificate of Course Completion iss ued to the attendee\, and archive of the PowerPoint and audio to keep fore ver

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\nMany products fall under the cosmetic-drug i nterface. These are products that may share the characteristics of both a cosmetic and drug\, as defined in the Food and Drugs Act\, making them mor e difficult to classify. Such products may include acne therapy\, anti-perspirants\, sunburn p rotectants\, tooth whiteners\, and many others. In Canada\, these products can be regulated by the Cosmetic Regulations\, Food and Drug Regulations\ , or the Natural Health Products Regulations\, depending on their ingredie nts and the claims t hey make. This webinar was created to help clarify how products of this na ture are classified\, to capitalize on allowable health claims\, and to sa ve time and money by avoiding unnecessary regulatory burdens as a result o f misclassification. Topics cove~~r ed include:~~
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·\; \; \; \; \; \; \; procedures on how to accurately classify your product as a c osmetic\, natural health product\, or drug
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·\; \; \; \; \ ; \; \; an overview of the regulatory requirements for each category and how the y differ\;
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~~·\; \; \; \; \; \; \;~~ instructions on how to mitigat e risk an ensure regulatory compliance\;
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·\; \; \; \; \;& nbsp\; \; strategies to capitalize on allowable\, unique and strong claims\; and\,
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·\; \; \; \; \; \; \; a list of product categories that have rec ently experienced a category transition.
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This seminar is being presented by William Morkel and Clara Di Tella.
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\nWilliam Morkel\, Senior Regu latory Affairs &\; Quality Assurance Specialist at dicentra\, has ten y ears of experience working in the field of pharmaceutical and natural heal th products quality assurance and regulatory affairs. Clara Di Tella is di centra’s primary advisor for regulatory affairs and labeling requirement s for cosmetics.
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