FDAnews Announces -- Quality Metrics Redux: Taking Advantage of FDA''s Renewed Focus Webinar, Oct. 17, 2018

Friday, October 5, 2018 Drug News
Email Print This Page Comment bookmark
Font : A-A+

Quality metrics are a scary but valuable opportunity for drugmakers. Steven Mendivil of Amgen and Denyse Baker of AstraZeneca will explain the latest developments and what they mean.

FALLS CHURCH, Va., Oct. 05, 2018 /PRNewswire-PRWeb/ -- Quality Metrics Redux: Taking Advantage of FDA's Renewed Focus

**An FDAnews Webinar** Oct. 17, 20181:30 p.m.3:00 p.m. ET http://www.fdanews.com/qualitymetricsredux

Quality metrics… A scary prospect? Maybe. A valuable opportunity? Almost definitely.

After more than a year in regulatory limbo the FDA is breathing new life into its proposed quality metrics program.

The agency began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation.

Mark the calendar for a strategy session with two knowledgeable industry activists, Steven Mendivil of Amgen and Denyse Baker of AstraZeneca. Over the course of fast-paced 90-minutes, they'll explain the latest developments and what they mean.

Attendees will discover:

  • How the pilot program is progressing and what the FDA has learned so far
  • How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel
  • Important details of the FDA's latest draft guidance on quality metrics, including what information is to be included in a meeting request and what information FDA would like to see during a site visit
  • Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them
  • And much more

Quality metrics is no longer a distant dream. It's coming and drugmakers need to prepare their quality system to meet it.

Meet the Presenters: Steven Mendivil is Senior Advisor for Quality/External Affairs at Amgen, where he formerly served as Executive Director of International Quality/External Affairs among other leadership positions during a 19-year stint with the major biotech firm. Previously he worked 15 years for Genentech, Syntex and SYVa in regulatory affairs, quality and manufacturing positions encompassing both drugs and devices.

Denyse Baker is Senior Policy Director-U.S. Regulatory Affairs for AstraZeneca, supporting policy development and advocacy on behalf of biosimilars, combination products and PDUFA VII. Over 30 years in pharma, she has held positions with the FDA (CDER) and Eli Lilly. She was a leader of the PDA's Pharmaceutical Quality and Culture metrics programs, as well as coordinator for the PDA Regulatory Commenting and PDA Taskforces ,working on data integrity and post-approval change affecting drugmakers.

Who Will Benefit: Drug and biologics makers distributing Rx or OTC products within the U.S. or holding marketing authorizations with FDA (NDAs, ANDAs, BLAs). Specific job titles include but aren't limited to:

  • Quality executives
  • Regulatory/compliance
  • Manufacturing/operations

Webinar Details: Quality Metrics Redux: Taking Advantage of FDA's Renewed Focus **An FDAnews Webinar** Oct. 17, 20181:30 p.m.3:00 p.m. ET http://www.fdanews.com/qualitymetricsredux

Tuition: $287 per site

Easy Ways to Register: Online:     http://www.fdanews.com/qualitymetricsredux                         By phone: 888-838-5578 or 703-538-7600

About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

 

SOURCE FDANEWS



Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store