Robert L. Kunka, Ph. D. speaker of compliance global

Speaker: Robert L. Kunka, Ph. D.
Duration: 60 Minutes
Product ID: 700124

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Paediatric Drug Development - Adult Data and Relevant FDA Laws.

Up until a few years ago FDA required pharmaceutical companies to duplicate the same studies that were required in adults in children. This requirement often prevented development in children becau more...

Adriaan Fruijtier speaker of compliance global

Speaker: Adriaan Fruijtier
Duration: 60 Minutes
Product ID: 700193

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Development regulatory affairs for Oncology Medicinal Products

Because malignant tumours are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desirable to provide new, effective anticancer d more...

Philip Vassallo speaker of compliance global

Speaker: Philip Vassallo
Duration: 60 Minutes
Product ID: 700205

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Writing Effective Email

Have you been on the receiving end of an email with an endless, useless recipient list? Have you struggled through the overlong, cryptic prose and twisted logic of an email only to realize you have more...

Sarah Fowler-Dixon speaker of compliance global

Speaker: Sarah Fowler-Dixon
Duration: 60 Minutes
Product ID: 700287

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10 Tips for Submitting Human Subjects Protocols

Institutional Review Boards (IRB) also known as ethics committees or ethical review boards were established by federal regulation in 1974. IRBs are independent committees designated to approve, mon more...

Charles H. Pierce speaker of compliance global

Speaker: Charles H. Pierce
Duration: 90 Minutes
Product ID: 700463

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Protocol Deviations and Violations:The importance of knowing how to prevent them

With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of “Not following the Protocol” has gained increasing importance. Protocol more...