Norma Skolnik
Regulatory Consultant at EAS Consulting Group & NS Consulting
Norma Skolnik works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A. Norma has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry. She was the Associate Director of Regulatory Affairs at Lederle Laboratories in Pearl River, N.Y. and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum and Caltrate dietary supplements. When Lederle was acquired by Wyeth, she became Associate Director of Regulatory Affairs there, acquiring more experience in the Dietary Supplement and OTC drug fields. She joined Warner-Lambert Consumer Health division in 1998 and became Assistant Director of Adams Regulatory Affairs. In 2002, when Pfizer acquired Warner Lambert she was promoted to Director of Regulatory Affairs for the Adams division. Adams was acquired by Cadbury-Schweppes in 2003 and she served as Cadbury Adams' Director of Regulatory Affairs for the Americas from 2003 until her retirement in 2008.

Norma earned a Bachelor's degree in Biology from the University of Cincinnati and holds a Master's degree from Pratt Institute in Brooklyn, New York. She's also done graduate work at Columbia University and Montclair State University.
Upcoming Webinar
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Recorded Webinar
USDA GMO Labeling - What to Expect from the 2018 Final Rule
In this webinar, speaker will outline both the history of this controversial topic and the industry standards for GMOs as they exist today-including how to abide by global, federal, and state rules and requirements. While a recently-passed federal law preempts state laws, there are tons of unresolved issues that can complicate your compliance. Don't get caught off guard.
Recorded Session Get life time access for one participant with download option!

FDA Regulation and Legislation of Cosmetics
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
Recorded Session Get life time access for one participant with download option!

Health Canada's Regulations on Natural Health Products vs. FDA's Dietary Supplement Regulations
This event will offer an overview of what Health Canada considers to be a Natural Health product and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
Recorded Session Get life time access for one participant with download option!

FDA's New Commissioner under Trump's Administration: The way forward for the FDA
How will the FDA change under the Trump administration and the new FDA Commissioner? This event will explore the implications of the Trump Administration and President Trump's pick of Dr. Scott Gottlieb as new FDA Commissioner and Tom Price as Secretary of Health & Human Services on the future of the FDA. The event will cover Trump's regulatory agenda, his deregulation task force at federal agencies and his proposed budgetary cuts. Trump's new pick for commissioner of the FDA will be discussed in detail as well as his intention to ease drug regulations and streamline the agency and the drug approval process.
Recorded Session Get life time access for one participant with download option!

FDA Action on Antiseptic Wash Products: What is Next for the Industry?
The FDA just banned 19 active ingredients that are used in antibacterial soaps. This major regulation will have a huge impact on this multi-million-dollar industry since the FDA Rule will require companies to remove these ingredients from their products or remove the products from the market. Manufacturers will have one year to take these products off the market or reformulate them. This presentation will cover FDA Action on Antiseptic Wash Products and what is next for the Industry.
Recorded Session Get life time access for one participant with download option!

Mandatory GMO Labeling: Preparing for Implementation
Public and scientific opinion on GMOs in the US is controversial and GMO labeling requirements have been a subject of much debate in the country. One of the U.S. states just enacted a GMO labeling law and a new Federal GMO Labeling law was passed in July 2016. Attend this webinar to learn about the status of GMOs in the U.S., how they are regulated by the FDA, FDA's Biotechnology Policy and Biotechnology Consultation program and GMO labeling in other countries. The session will cover all FDA regulations and policies regarding GMOs as well as important new federal, state and consumer GMO labeling initiatives.
Recorded Session Get life time access for one participant with download option!

U.S. OTC Drug Labeling Regulations & Requirements
This presentation provides an overview of FDA OTC Drug regulations with a focus on OTC Drug Labeling requirements. It will help the attendee understand basic regulatory requirements for marketing and labeling OTC drugs successfully in the U.S.A.
Recorded Session Get life time access for one participant with download option!

Health Canada's Regulations on Natural Health Products vs. FDA's Dietary Supplement Regulations
This event will offer an overview of what Health Canada considers to be a Natural Health product and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
Recorded Session Get life time access for one participant with download option!

Labeling of genetically modified organisms (GMO's) in the USA
Attend this webinar to learn an overview of the status of GMO's in the U.S., how they are regulated by the FDA, FDA's Biotechnology Policy and Biotechnology Consultation program and GMO labeling around the world. The session will refer to all FDA regulations and policies regarding GMOs as well as proposed federal, state and consumer GMO labeling initiatives.
Recorded Session Get life time access for one participant with download option!

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