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Natural History Studies in Rare Diseases and Genetic Biomarkers

By Andrew Bevan, director, project management, peri- and post-approval operations, Evidera; Moira Ringo, senior consultant, real-world evidence, Evidera; Leona C. Fitzgerald, senior director, regulatory affairs, PPD; Fiona Kearney, senior director, project management, peri- and post-approval operations, Evidera; and Delphine Saragoussi, research scientist, real-world evidence, Evidera.

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Successful partnering in pharmacovigilance for clinical trials

Successful partnering in pharmacovigilance for clinical trials

Gary Barker, Denise Moody, Magda Santos and April Pierce provide insight into creating and keeping a successful pharmacovigilance partnership with a functional service provider.

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Local regulatory affiliates

The future of the local regulatory affiliate: Adjusting to global strategies, processes and expectations

Alistair Davidson, senior director, regulatory affairs, discusses the work of local regulatory affiliates.

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Positive changes in the Latin American clinical trial regulatory environment

Positive changes in the Latin American clinical trial regulatory environment

Andres Bayona, executive director in clinical monitoring and regional head of Latin America, and Mercedes Ponce de Leon, senior manager in regulatory affairs, discuss the clinical trial regulatory landscape in Latin America.

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First-in-health regulatory changes Kirsten Messmer

Seeking ways to ensure participant safety in first-in-human trials

Kirsten Messmer, Ph.D., R.A.C., principal regulatory affairs specialist, details changes in regulatory guidelines for first-in-human trials.

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