Page 1

Live Webinar


Dietary Supplements and OTC Drugs - Adverse Event Reporting

Date & Time: Tuesday, August 09, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Norma Skolnik

Location: Online

Price : $245.00


Register Now

(for one participant)

Instructor Profile:


Norma Skolnik Senior Consultant, EAS Consulting

Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will b e able to answer.

Why you should attend: There are often questions about what FDA considers to be an adverse event and about Adverse event reporting requirements for Dietary Supplements and OTC drugs. This Webinar will help to answer those questions and will help assure manufacturers and

importers that they comply with the law.

Areas Covered in the Session:



Adverse event reporting and recordkeeping requirements of the Dietary Supplement &Nonprescription Drug Consumer Protection Act Questions & Answers regarding the Labeling of Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

Norma Skolnik has 30 years of regulatory experience in the OTC Drug, Food and Dietary Supplement industries. She has had extensive experience advising on regulatory strategies for new and marketed consumer healthcare products. Particularly regarding the development and review of optimal product claims and advertising. For 10 years, Norma served as Director of Regulatory Affairs for Cadbury Adams, Americas (formerly Adams Division of Pfizer). Previously she was Associate Director of Regulatory Affairs at Wyeth Consumer Healthcare and Associate Director, Regulatory Affairs at Lederle Consumer Health division of American Cyanamid....more

Suggest a Topic

More Webinars

Your Necessity is our Priority

Click here to register for this webinar Who Will Benefit:

Anyone who wants to market OTC drugs in the U.S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/webinar:


Regulatory Professionals Drug Marketers Manufacturers and Distributors


Students of FDA Regulations

l l

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals.

GlobalCompliancePanel 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Dietary Supplements and OTC Drugs - Adverse Event Reporting  

Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adver...

Read more
Read more
Similar to
Popular now
Just for you