HOUSTON, Tx. — April 26, 2018. Pharm-Olam International, a global, full-service Contract Research Organization (CRO) specializing in Oncology, Infectious Diseases & Vaccines, Rare Diseases and Pediatric indications, is prepared for the implementation of the European Union’s (EU’s) General Data Protection Regulation (GDPR), which will impact our industry among others where organizations collect and hold personal data on EU citizens. Utilizing Pharm-Olam’s version of the Bow Tie Methodology for visual risk assessment and management, powered by Ideagen’s Q-Pulse software, Pharm-Olam is fully prepared for the global GDPR roll-out. In anticipation of GDPR’s effective date (May 25, 2018), Pharm-Olam will be hosting an interactive 60-minute live training webinar on May 15, 2018 at 11a.m. EST for its pharmaceutical and biotechnology partners and clients. Registration and attendance is open to the public.
GDPR will go into effect on May 25, 2018 enforcing a strict set of new rules concerning privacy and data security and imposing strict penalties on violators. It effects anyone holding data on EU citizens, including those companies not based in the EU. The new regulation is intended to unify data protection laws and requirements to ensure citizen’s personal data is completely secure. In anticipation of GDPR, Pharm-Olam is communicating about its risk management process (visual Bow Tie Methodology) and how it forms the foundation for our organization coming into compliance with GDPR.
The Bow Tie Method continues to become a further integral component of every trial Pharm-Olam manages and conducts, from study level to functional level to procedural level. Pharm-Olam’s Bow Tie Method facilitates compliance with the new ICH E6 R2 language for sponsors monitoring their partnering CROs. Unlike other risk management processes that measure risks on a scale, Pharm-Olam’s Bow Tie Method considers and integrates project milestones and uses them to form and measure Key Performance Indicators.
Pharm-Olam will hold a live webinar discussing GDPR and how your organization can be made ready on May 15, 2018 at 11:00 a.m. EST, detailing aspects of GDPR such as:
- What is GDPR?
- What impact does GDPR have on your organization and on clinical trial conduct?
- What do you need to have in place to comply with the regulation?
- Are there differences in country-by-country interpretation?
- How Pharm-Olam’s Bow Tie Method was utilized to manage our compliance readiness?
- Where you can turn for assistance and adaptation during transition?
The webinar will be led by Pharm-Olam’s Data Protection Officer Natasa Spasic, who is trained and certified in GDPR regulations, and hosted by Dr. Yamin ‘Mo’ Khan, Executive Vice President, Global Clinical Development at Pharm-Olam.
To register for the webinar, please visit: http://www.pharm-olam.com/gdprwebinar
About Pharm-Olam International
Pharm-Olam International is a multinational Contract Research Organization (CRO) offering comprehensive clinical research services to the pharmaceutical, biotechnology and medical device industries. From Phase I to Phase IV, Pharm-Olam focuses on delivering the highest quality data, achieving targeted enrollment and meeting projected timelines, making clinical research as Easy As I, II, III, IV™. Pharm-Olam specializes in the conduct of clinical trials in Oncology, Infectious Disease and Vaccines, Rare Diseases, and Pediatric indications as well as continuing to support various other therapeutic areas within General Medicine. For further information about Pharm-Olam, please visit www.pharm-olam.com.