spacer
home > ebr > spring 2018 > rules for success
PUBLICATIONS
European Biopharmaceutical Review

Rules for Success

Over the past 40 years, the role of regulatory professionals has changed immensely. Factors such as the rapid pace of technological innovation, heightened global safety issues, and different and changing regulatory environments are just a few of the challenges that influence the regulatory landscape and, in turn, shape the profession.

In those years, some regulatory societies have seen their membership evolve as the dynamics of the profession have pivoted to meet regulatory and strategic demands. Membership has transformed from a collection of individuals from varied fields, tasked with the administrative aspects of a growing body of requirements, to a group of professionals who engage with the entire product lifecycles of their respective organisations. Regulatory teams link science, technology, and innovation with clinical needs and maintain a watchful eye on compliance and developments, policy, and good business practice.

This article discusses the evolving role of regulatory within the pharmaceutical industry, the importance of having a competent workforce, and how this profession can be a strategic driver of organisational success.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr William Bridges joined the Regulatory Affairs Professionals Society as Vice President of Education and Professional Development in January 2017. In his 20 years of experience, he has designed instructional materials and curriculum, created a vision for education and training programmes, and developed competency-guided roadmaps for learners in the military, academia, government, and association spheres. He also holds a PhD in history from the University of Nebraska, US and has taught for the University of Nebraska, US, Towson University, US, and the American public university system.
spacer
Dr William Bridges
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

New to the PPMA Show 2018: Bright Ideas - Ambassador Programme

A new initiative for PPMA Show visitors this year is the Bright Ideas - Ambassador Programme - a free advice service for start-up ventures and entrepreneurs.
More info >>

White Papers

Delivering Fit For Purpose Biomanufacturing CHO Cell Lines

Fujifilm Diosynth Biotechnologies

The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
More info >>

 
Industry Events

PDA Universe of Pre-Filled Syringes and Injection Devices

8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL

At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement