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Pregnancy and Prescription Medication Use Symposium – Round Table Discussion

Pregnancy and Prescription Medication Use Symposium – Round Table Discussion. Tayo Fadiran, R.Ph., Ph.D. Senior Health Programs Coordinator Research & Development, OWH, FDA. Discussion Questions.

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Pregnancy and Prescription Medication Use Symposium – Round Table Discussion

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  1. Pregnancy and Prescription Medication Use Symposium – Round Table Discussion Tayo Fadiran, R.Ph., Ph.D.Senior Health Programs CoordinatorResearch & Development, OWH, FDA

  2. Discussion Questions • In giving advice to other researchers planning to conduct trials in pregnant women, what do you see as the most important elements? For example: • Recruitment strategies - what worked, what didn’t? • What healthcare provider/clinicians/clinics relationships were required for successful recruitment? • What was your experience with the IRB review of the proposal?

  3. Discussion Questions What are the greatest hurdles to the conduct of clinical trials in pregnant women? 

  4. Discussion Questions Do you have any specific suggestions for future PK studies in pregnant women?

  5. Discussion Questions What general recommendations do you have for future research in pregnant women?

  6. Presentation slides and web cast The presentation slides and the web cast of the symposium will be available soon at: FDA Women’s Health Research Home Page www.fda.gov/womenshealthresearch Please complete your evaluation form. Thanks!

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