What CDER Can and Can’t Do: An Inside Look from an Agency Official Webinar, Aug. 23, 2018

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Every new-drug approval must pass muster with patients. A CDER insider shows how that works.

FDAnews

FDAnews

What CDER Can and Can’t Do:
An Inside Look from an Agency Official
**An FDAnews Webinar**
Aug. 23, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/whatcdercanandcantdo

When patients and caregivers talk, does CDER listen?

It tries hard, says CDER official Dr. Sadhna Khatri. Since 1991 the office has made moves to strengthen patient and caregiver input during the drug approval process, helped along by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) that took effect in 2012.

Drug development lives and dies with CDER. That’s why FDAnews has reached out to Dr. Khatri for an insider’s view on a matter that may affect every drug and biotech firm with new products up for FDA approval.

Over the course of a fast-paced hour and a half, attendees discover what CDER can and can’t do, and how that affects them. Here’s just a sampling of what Dr. Khatri plans to cover:

  • The patient voice: What CDER does to help patients get heard on drug approval, safety and efficacy issues
  • Speedier review: What CDER can do to speed approvals
  • What CDER can’t do: Limitations placed by law and regulation
  • FDASIA: How the 2012 law expands and strengthens agency ability to safeguard public health
  • Real-world examples: Engagement strategies that work for others
  • How to deal with CDER: Face-to-face, electronically and via postal mail
  • How to request a meeting with CDER
  • And much more!

Think for a moment about the role that public input plays in drug approvals. Patients experience diseases and therapies differently, and each has his/her own perspective on treatments and diagnostic procedures. Drugmakers need the patient perspective for their success. An agency outreach specialist shows what that looks like.

Meet Your Presenter:
CDR Sadhna Khatri, PharmD MPH MS MEd is a regulatory officer in Professional Affairs and Stakeholder Engagement (PASE), Office of the Center Director, CDER, where she evaluates a wide range of drug safety issues with an eye toward mitigating risk and its impact on public health. She develops strategic contacts and outreach to other agencies, professional organizations and societies, and works with patient advocates to increase engagement with the FDA and strengthen the patient voice in the drug development process. Previously she was associated with CDER’s Division of Drug Information, responding to public inquiries, and FDA’s MedWatch program. She was also director of the FDA’s Pharmacy Student Experiential Program (PSEP).

Who Will Benefit:

  • Quality professionals
  • Regulatory/compliance
  • Patient advocates
  • Health care professionals

Webinar Details:
What CDER Can and Can’t Do:
An Inside Look from an Agency Official
**An FDAnews Webinar**
Aug. 23, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/whatcdercanandcantdo

Tuition:
$287 per site

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

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