International Compliance Training -- Expanding Your Business Overseas

Clinical compliance is a key activity in the management of laboratories, not only to ensure the validity of any trials conducted, but also the health and safety of employees in the lab. International regulations tend to differ in the practice and implementation of these protocols, so any pharmaceutical company with a Regulation EU2016/679 international footprint or looking to expand overseas must have professionals trained in clinical compliance for each country or region of operation.

If you are a pharmaceutical professional seeking compliance training for the European Union, CfPIE offers the Understanding & Implementing New EU Clinical Trial Regulation & GDPR course to ensure you have the toolkit in place to operate in the EU.

With the eventual departure of Britain, there are new policies in place that affect clinical trials and the regulation of laboratories, including the regulation of data collected from individuals participating in clinical trials. Additionally, the countries of the EU each have differing policies that any US-based pharmaceutical company will be expected to comply with.

The EU Directive (2001/20/EC) was replaced with the new EU Clinical Trials Regulation (No 536/2014) in 2016, and any companies not currently operating in the EU may be unaware of the changes required for the submission, review and approval processes of clinical trials in EU nations.** More recently, Regulation EU2016/679, passed in 2018, mandates that any piece of information which can be used to identify an individual must be collected with consent and stored in accordance with the Regulation.

Successfully producing and marketing a new product in international markets is the way forward for many US-based businesses, and this course also covers the Asian market in some detail to give professionals an understanding of the challenges of regulatory practice in those countries, which have been experiencing the greatest growth of any other region.

In addition to the Understanding & Implementing New EU Clinical Trial Regulation & GDPR, CfPIE also offers courses in European Regulatory Procedures, European Union Regulatory Issues and Filing Variations in the European Union, designed specifically for American professionals who want a 360-degree view on expanding their business or working as Compliance Officers in Europe.

The Understanding & Implementing New EU Clinical Trial Regulation & GDPR is part of the following certification programs: Clinical Compliance Certified Professional™ and Global Regulatory Affairs Compliance Professional™

** Source: https://www.clinicalleader.com/doc/initiating-multinational-clinical-trials-major-differences-between-the-u-s-and-eu-0001