FDAnews Announces — Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women Webinar, Feb. 24, 2016

Share Article

Generating real-world evidence is essential to uncovering the potential effects a product may have on pregnancy outcomes, particularly for women of childbearing age that require chronic therapy for diabetes, depression, epilepsy, asthma and more. Understanding key regulatory guidance points and the most vital considerations in pregnancy registry design will allow drugmakers to efficiently create and summarize the data needed for regulatory reporting.

Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women
**FDAnews Free Webinar**
Feb. 24, 2016 — 1:30 p.m. – 2:30 p.m. EST
http:// http://www.fdanews.com/safetydatacollectionpregnantwomen

Generating real-world evidence is essential to uncovering the potential effects a product may have on pregnancy outcomes, particularly for women of childbearing age that require chronic therapy for diabetes, depression, epilepsy, asthma and more.

Understanding key regulatory guidance points and the most vital considerations in pregnancy registry design will allow drugmakers to efficiently create and summarize the data needed for regulatory reporting.

On Feb. 24 a complimentary webinar will be presented by Dr. Catherine Sigler, a leading epidemiologist who has designed, developed, conducted and analyzed pregnancy exposure registries. She will show attendees the benefits of using proactive registry design and planning through a case study of a pregnancy registry.

This webinar will cover:

  •     The relationship between prescription drug use and birth outcome information
  •     The guidelines for when it is appropriate to conduct a pregnancy registry from the EMA and FDA
  •     How to implement processes that ensure patients receive appropriate follow up communications to ensure reporting success
  •     How well-designed and documented pregnancy exposure registries hold promise of allowing prescribers to best advise their patients and help pregnant women make better-informed decisions regarding the best therapeutic choices during pregnancy

At the end of this webinar attendees will be better versed in regulatory guidances regarding pregnancy registries and be able to consider options for study design and execution. Additionally, attendees will know the most common challenges encountered by those who work on pregnancy registries and strategies for success. In Particular attendees will learn:

  •     How and when to ask the right questions about pregnancy registry design
  •     Which communications processes drugmakers can implement to impact reporting success
  •     How the FDA and EMA evaluate pregnancy registry requirements
  •     Considerations for pregnancy registry design that will impact patient outcomes

Who Will Benefit:
Individuals involved in:

  •     Regulatory Affairs
  •     Chief Medical Officer/Med Affairs
  •     Clinical Research
  •     Safety
  •     Risk Management

Meet the Instructor:
Catherine Sigler, PhD

Executive Director, Safety, Epidemiology, Registries, and Risk Management (SERRM)
Catherine Sigler, PhD, joined UBC as a Senior Director of SERRM in 2007. In her current position as Executive Director, she has responsibility for UBC’s SERRM and Value Demonstration teams. She serves as a pharmacoepidemiologist and senior scientist, providing scientific oversight and regulatory advice for observational studies. In addition, she is a team lead for epidemiology studies with a focus on pregnancy registries and works closely with sponsors to develop risk minimization action plans.

Webinar Details:
Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women
**FDAnews Free Webinar**
Feb. 24, 2016 — 1:30 p.m. – 2:30 p.m. EST
http://www.fdanews.com/safetydatacollectionpregnantwomen

Easy Ways to Register:
Online:     http:// http://www.fdanews.com/safetydatacollectionpregnantwomen
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.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website