Articles by Ansis Helmanis - Pharmaceutical Executive

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Articles by Ansis Helmanis

Ansis Helmanis


Ansis Helmanis is a former FDA official and founder of RegLink Associates.

Articles
IP: Securing a Global Consensus—Can Industry Do It Again?
October 1, 2011

Harvey Bale, Jr., MD, former Director-General, IFPMA

Jane Henney: Lessons from the FDA Front Line
October 1, 2011

Jane Henney, MD, Former FDA Commissioner

A New Twist in the Cost Curve
December 1, 2010

The strict regulatory divide between market authorization and price reimbursement iscrumbling in the US. Is industry prepared to adapt or challenge?

Managing REMS for the Long Term
March 1, 2010

Obligations to fund and support costly studies can extend beyond the period of market exclusivity, giving generics competitors an advantage.

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