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

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

Changing Structural Landscape for Comparator Drug Supply

ADAllen Pharma

TransCelerate Biopharma is focused on advancing innovation in R&D, identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. In 2013, they announced its Clinical Trial Comparator Network initiative to show a mutual commitment to offer secure and rapid supply of comparator drug products. The aim of this article is to unpack the section on 'Comparator Drugs' and analyse the rationale for attempting to achieve their objectives.
More info >>

 
Industry Events

PDA Parenteral Packaging 2019

19-20 March 2019, Hilton Molino Stucky, Venice, Italy

PDA Europe’s Conference has become a must-attend event for all professionals in the Parenteral Packaging arena. Join us in Venice in March 2019 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. This conference and the accompanying exhibition address quality of components and cont­ainers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement