Organization Name / Organize By
Compliance Key
Organizing/Related Departments
IT,Risk management,Finance,HR,FDA
Organization Type
Training/Development
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Administration/Management
Medical/Healthcare/Hospital
Location
Middletown,DE,USA,Delaware,United States
Topic : 2020 CARES Act & OTC Drug Reform
Register : https://www.compliancekey.us/webinar/1701/cares-act-otc-drug-reform/source_egln
Offer : (10% Off) On New Signup
Overview
The recently passed 2020 CARES Act includes an important section that significantly reforms the regulatory framework for OTC drugs and makes important changes to how FDA regulates drugs marketed under an OTC Monograph. It is likely to yield greater OTC access to drug ingredients with strong safety profiles.
Areas Covered in the Session :
- How the OTC Drug Monograph Safety, Innovation & Reform Act replaces the FDA notice and comment rulemaking with an administrative order process.
- How changes under the CARES Act help clarify the regulatory status of OTC drugs now subject to Tentative Final Monographs.
- Pathways for new OTC active ingredients and new drug dosage forms for drug products under the Act.
- FDA's 2019 proposed Sunscreen rules and how these will change under the CARES Act.
Speaker Profile :
Norma Skolnik is Keynote Speaker at ComplianceKey. She has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.
Contact Info :
Compliance Key
https://www.compliancekey.us/
Email : [email protected]
Phone : +1 717-208-8666
Others Details
Virtual event
Registration Fees
Available
Registration Fees Details
Single Attendee: [Only for one participant]
$179 (Live) $286 (Live + Recorded)
Multiple Attendee: [For a group of 2-5 participants]
$453 (Live) $811 (Live + Recorded)
Corporate Attendee: [For a group of 6-10 Participants]
$896 (Live) $1324 (Live + Recorded)
Recorded: [Six month unlimited access]
$193 (Single Attendee) $449 (Unlimited Attendee)
Registration Ways
Email
Phone
Website
Address/Venue
Online Event,Compliance Key,364 E Main Street, Suite 1009
Pin/Zip Code : 19709