Pharmaceutical Communiqué: Q2 – 2009

Now Updated GMP Training for EU Compliance

Despite years of work, the promise of a single, global regulatory standard for pharmaceutical manufacturing practices has not materialized. 
 
US-based companies face the regulatory challenge of FDA compliance no matter where they produce their products.  They also face non-US regulations, whether EMEA-issued requirements for products manufactured Europe or nation-specific compliance standards that directly affect their suppliers' manufacturing operations. The compliance challenge exists for products manufactured in the US and destined for non-US markets - but it also applies to those pharmaceutical products manufactured around the world for US consumers.

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New Library for Pharmaceutical/Healthcare Professional Interactions

Legislators, regulators and industry groups are joining forces to enforce strict controls on the interactions of pharmaceutical representatives and Healthcare Professionals (HCPs).  
 
Most important is the new  "Code on Interactions with Healthcare Professionals," issued by The Pharmaceutical Research and Manufacturers of America (PhRMA). 

Pharmaceutical companies are responding through intensified training of employees and subcontractors to ensure that their actions are ethical, compliant and supportive of optimal patient care.

Kaplan EduNeering' has released a new Pharmaceutical Library focused on Pharmaceutical/Healthcare Professional Interactions, marketing and sales, continuing education and product promotion. 

The eight-course library provides in-house and field pharmaceutical personnel with in-depth coverage of rules, policies, regulations and guidance issued by organizations including FDA, PhRMA, OIG and ACCME. 

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