Tuesday, 24 April 2018Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA
The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.
In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey)
Friday, 20 April 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
EU GDPR Overview
The General Data Protection Regulation (GDPR), approved by the European Parliament and Council in April 2016, replaces the Data Protection Directive 95/46/ec. When this regulation goes into effect on May 25, 2018, it will become the primary regulation protecting all European Union (EU) data subjects from privacy and data breaches in a world driven by data -- a world very different from the time in which the 1995 directive was established.
Friday, 13 April 2018Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company
Earlier this week we shared the first in a two-part series on practical tips for managing supplier risks in the Life Sciences industry. In the previous post
we discussed how resource planning, understanding the rules, preparation, and planning lay the foundation for a successful supplier-risk management program. In today’s post we’ll provide practical tips for setting goals, coaching recommendations, and best practices for supplier performance and risk monitoring.
Tuesday, 10 April 2018Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company
It is critical today that risk-based thinking be embedded across respective quality and compliance activities throughout the Life Sciences. ISO13485:2016 regulations are driving the industry to this paradigm. I recently explored practical tips for managing life sciences supplier risks together with a team of consultants, including Dr. Carmine Jabri of E.M.M.A. International Consulting Group
, Aida Markham of QACV Consulting
, and Kenneth Christie of VTS Consultants, Inc
. This post is the first in a two-part series that examines our findings, which you also can uncover on-demand here
Tuesday, 03 April 2018Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions, an IQVIA company
This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.
Pilgrim is here to help you along the path to compliance. Are you ready to move forward?