WEBINAR


FDA's Pregnancy & Lactation Labeling Rule

Best practices to easily revise, submit and  pass FDA validation for your label

Thursday     •      May 14, 2020      •     11:00 am  ET

Industry experts, Gary Saner, Sr. Manager of Information Solutions, Reed Tech Life Sciences Group and Chris McGahan, Director, Global Labeling Center of Excellence, PRA Health Sciences will share their experience and lessons learned supporting the PLLR process. They’ll discuss:

  • Which drug labels need to comply with the FDA’s PLLR
  • Best industry practices to revise the Pregnancy label sections per PLLR
  • How to easily submit revised labeling in SPL format to the FDA and pass FDA validation

PRESENTERS

Gary Saner Picture-1
GARY SANER

Sr. Manager of Information Solutions  
Reed Tech Life Sciences

Gary Saner is a subject matter expert on Medical Device UDI, Drug Labeling, and other structured content reporting to regulatory agencies and commercial organizations. He has over 35 years of experience in the areas of software development, process management, and data administration with the last 15 years focused on the Life Sciences industry. With an understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation and processing of Medical Device UDI and Drug Labeling content. He serves as co-chair of the industry’s Structured Product Labeling (SPL) Technical Team and on the Advisory Board of the Medical Devices Group.

 

CHRIS McGAHAN

Director, Global Labeling

PRA Health Sciences

Chris McGahan heads the Global Labeling Center of Excellence within PRA’s Global Regulatory Affairs group. Chris is a regulatory affairs professional with over 20 years of experience in the biotechnology and pharmaceutical industries. Areas of expertise within Global Labeling include End-to-End drug labeling development, submission and implementation; including CCDS, local prescribing/patient information labeling, and carton/container labeling. She specializes in Structured Product Labeling (SPL), US labeling regulations and guidance, labeling technologies, plus global labeling processes and policies

 

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