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 No “cookie cutter” approach to product safety

Public access to information about drug safety is increasing with more real time information available to consumers that ever before in Europe and the US.

However, with the advent of social media, product discussions are happening online in real time and often with little or no opportunity for informed health care professionals to weigh in.

That’s the view of Stephen Klincewicz, Global Head of Drug Safety for Bayer Consumer Care.

Klincewicz was a speaker at the marcus evans Global Pharmacovigilance and Adverse Event Reporting Forum that was held on May 11-13 in Philadelphia, PA.

There are a number of increasing complexities in managing drug safety today, says Klincewicz.

“Over the past decade there was a lot of interest in global regulatory harmonisation as evidenced by the many International Conference on Harmonization (ICH) and Council for International Organizations for Medical Science (CIOMS) initiatives. While there has been a lot of successes, there are still some differences, for example between member states in the EU and between the US, EU and Japan.  The challenge for medicinal product companies will be to recognize these differences and not expect a “cookie cutter” approach to product safety.

“Public access to information about drug safety is increasing. If you look at the websites in the EU and US, more real time information is available to consumers that ever before.  Even PSURs are now available to the public.”

Social media may be having a big impact, he says.

“Product benefits as well as risks (real or perceived) can now be discussed online in real time and often with little or no opportunity for informed health care professionals to weigh in.”

However, drug safety across the globe is being promoted by European Medicines Agency (EMEA) legislation and rulings, he adds.

“Each national and supra-national system pharmacovigilance system is different.  Certainly the EU were pioneers in focusing on the establishment and oversight of the entire pharmacovigilance system and they have also established many scientific committees that thoroughly and expertly review safety issues. 

“And their EPAR (European Product Assessment Report) provide transparency and access not only to EU citizens but globally. Each of the global health authorities has different approaches to PV.  And rather than trying to harmonize, I think that PV professionals’ time is better spent thoroughly understanding the different systems and adopting best practices.”

The marcus evans Global Pharmacovigilance and Adverse Event Reporting Forum was held May 11-13 in Philadelphia, PA.







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