Pharmaceutical Industry Consulting

Pharmacovigilance, from pharmakon (Greek ‘medicine’) and vigilia (Latin ‘to keep watch’):
to monitor the safety of medicines and take steps to reduce their risks and increase their benefits.

Specialty: Pregnancy Registries

  • Development of pregnancy exposure registry programs

  • Registry design, operation, program evaluation 

  • Data collection, data review, and communication 

  • Independent Advisory Committee leadership, membership

Providing project and operational support in pharmacovigilance and drug safety surveillance, clinical risk management, aggregate reporting, and regulatory documentation.

Specialty: FDA Guidance on the Inclusion of Pregnant Women in Clinical Studies

  • Interpretation of the guidance

  • Implementation strategies

  • Information for IRBs

Questions?

Feel free to contact me if you have any questions. Fill out a short form or email me directly at kristine@kristineshieldsauthor.com

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