Drug safety regulations increase need for industry resources and expertise

Safety requirements for drug manufacturers now extends through drug lifecycle, requiring more resources to track safety post-sale as well as building it in during design and manufacturing.

06/23/2009


According to the report, “Safety First: The Impact of New Regulations on Clinical Development,” drug safety leaders in pharmaceutical and biotechnology companies recognize the need to increase resources, either internally or through partnerships, to comply with the safety regulations recently issued by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA). The report is based on a survey of 140 industry safety specialists, including heads of medical, drug safety, and regulatory departments within large and mid-sized pharmaceutical companies and biotech firms. The survey found that more than three-quarters (77%) of respondents believe that new safety regulations have had a considerable impact on the industry as companies implement drug safety regulations throughout the clinical development process.
The FDA and EMEA have recently introduced more rigorous safety regulations, with a particular emphasis on post-marketing surveillance, to ensure that medications are monitored for their safety and effectiveness over the long term, across wide populations, and in real-life settings. The survey findings also highlighted regulatory departments as having the most immediate need for greater resources, with more than half of those surveyed (53%) saying they’ll need more help within the next six months.
"The transition from performing passive post-marketing surveillance to active safety monitoring using Phase IV studies, safety registries and comparative effectiveness programs, is to ensure that benefit/risk re-assessment continues as safety information on the real-world use of products is revealed. Although initially resource intensive, this more rigorous approach to obtaining and analyzing post-approval safety data will better ensure the public's confidence in a product's true safety profile. The real challenge will be to find better tools and novel approaches to implement the requirements of regulations efficiently and cost effectively," says Dr. Suzanne Gagnon, Chief Medical Officer, ICON Clinical Research.
The report was commissioned by ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, and developed by IMS Health, a provider of market intelligence to the pharmaceutical and healthcare industries.
Access other Control Engineering content related to the pharmaceutical industry regulations:


- Edited by David Greenfield , editorial director

Control Engineering's Sustainable Engineering News Desk

Register here .





No comments
The Top Plant program honors outstanding manufacturing facilities in North America. View the 2013 Top Plant.
The Product of the Year program recognizes products newly released in the manufacturing industries.
The Leaders Under 40 program features outstanding young people who are making a difference in manufacturing. View the 2013 Leaders here.
The new control room: It's got all the bells and whistles - and alarms, too; Remote maintenance; Specifying VFDs
2014 forecast issue: To serve and to manufacture - Veterans will bring skill and discipline to the plant floor if we can find a way to get them there.
2013 Top Plant: Lincoln Electric Company, Cleveland, Ohio
Case Study Database

Case Study Database

Get more exposure for your case study by uploading it to the Plant Engineering case study database, where end-users can identify relevant solutions and explore what the experts are doing to effectively implement a variety of technology and productivity related projects.

These case studies provide examples of how knowledgeable solution providers have used technology, processes and people to create effective and successful implementations in real-world situations. Case studies can be completed by filling out a simple online form where you can outline the project title, abstract, and full story in 1500 words or less; upload photos, videos and a logo.

Click here to visit the Case Study Database and upload your case study.

Bring focus to PLC programming: 5 things to avoid in putting your system together; Managing the DCS upgrade; PLM upgrade: a step-by-step approach
Balancing the bagging triangle; PID tuning improves process efficiency; Standardizing control room HMIs
Commissioning electrical systems in mission critical facilities; Anticipating the Smart Grid; Mitigating arc flash hazards in medium-voltage switchgear; Comparing generator sizing software

Annual Salary Survey

Participate in the 2013 Salary Survey

In a year when manufacturing continued to lead the economic rebound, it makes sense that plant manager bonuses rebounded. Plant Engineering’s annual Salary Survey shows both wages and bonuses rose in 2012 after a retreat the year before.

Average salary across all job titles for plant floor management rose 3.5% to $95,446, and bonus compensation jumped to $15,162, a 4.2% increase from the 2010 level and double the 2011 total, which showed a sharp drop in bonus.

2012 Salary Survey Analysis

2012 Salary Survey Results

Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Society for Maintenance and Reliability Professionals an organization devoted...
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.