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Managing Safety Reporting
for Advanced Therapies

A WCG | CenterWatch FREE Webinar
Tuesday, May 22, 2018 • 1:30 p.m. - 2:30 p.m. EDT

Advanced Therapy Medicinal Products (ATMPs) are at the cutting edge. The profit potential is enormous, as is the potential benefit for patients with now-untreatable or incurable conditions.

But as anyone who’s been there knows, the cutting edge can be a cold and dicey place.

  • How will patients react to gene therapy and other novel treatments?
  • What challenges are associated with developing, monitoring and reporting safety profiles and determining the benefits vs. risks?
  • Most pressing of all, how do you adapt your safety reporting under systems that were designed decades ago for traditional drugs?

Angela Pitwood, VP-Pharmacovigilance at Vigilare International, a WIRB Copernicus Group (WCG) subsidiary, has spent years working with all types of products both in clinical development and post approval. She can share with you the best ways to meet compliance for products used in personalized medicine.

This FREE webinar features an hour with Ms. Pitwood:

  • Discussing cutting-edge therapies that offer hope for conditions for which there are limited or no therapeutic options now …
  • Looking at how they work and how they’re developed …
  • FDA safety reporting now: What the agency can do, what it does do …
  • FDA safety reporting to come: New mechanisms the agency may apply to such therapies …
  • And much more!

ATMPs promise a bounty of new profits for drug and biotech makers … and a host of headaches on the road to that goal. This FREE sponsored webinar offers an edge in a competitive new area. Sign up now!


Who Will Benefit

Biotech companies with ATMPs or companies partnering with the innovator of therapies such as gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products and tissue-engineered products. Specific job responsibilities include:

  • Pharmacovigilance/drug safety staff
  • Medical reviewers
  • Safety associates
  • Safety scientists
  • Drug safety managers
  • Regulatory affairs staff
  • Clinical trials staff
  • Monitors

Sign Up for FREE Below

Meet Your Presenter

Angela Pitwood

Vice President of Pharmacovigilance
Vigilare

Angela Pitwood, Vice President of Pharmacovigilance at Vigilare, has spent years on the firing line of combination product post-market reporting and compliance. She’ll share with you her secrets and tips for compliance with the Final Rule so you can avoid legal hot water.