GLOBAL Safety Issues


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The reform package is essentially a watered-down version of the reforms that were originally proposed by the EU Industry Commissioner Günter Verheugen, meaning that it is less pro-industry than first thought, says Mitra Thompson, senior analyst, at IHS Global Insight.
“The main blow to brand-name pharma companies is that the promised ban on drug repackaging has been shelved,” she says. “The industry had been hoping the ban would crack down on competition from parallel traders. A positive impact on the industry will be more flexibility in the way that producers can approach consumers with information, thanks to the loosening of advertising products in specialist Internet and print media. Manufacturers also will have to develop closer ties with their wholesalers and suppliers and ensure that they only work with wholesalers that are on the European Medicines Agency’s approved list.”
Raymond Panas, Ph.D., director of international clinical development at Sucampo Pharmaceuticals, says the modernization of pharmacovigilance models is gaining in popularity…

Global Regulatory Trends
Drivers of and Constraints on the Applicability of Evidence-Based Medicine
Approved Biosimilar Products

Experts on this topic
Patricia Lovell Hoare, Chiltern
Dr. Raymond Panas, Sucampo Pharmaceuticals