Archive for the 'Information Technology' Category

Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanIn Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success. Part 2 outlines how unified communications (UC) can help overcome some of these challenges.

Any UC deployment is about connecting people with one another (and with data) in a faster, richer, simpler way. Of course, no technology is a silver bullet, and a firm will only realize the full benefits if it is a truly collaborative organization, or making serious efforts to become one.

As well as the right type of culture, companies also need to have appropriate infrastructure in place to support such a solution. For example, getting different modes of communication such as voice, video, and text working together seamlessly requires the right underlying network and hardware. While that could be an in-house system, for smaller and mid-market firms, a hosted, cloud-based offering that allows you to avoid hefty set-up costs is often a more cost-effective and hassle-free option. Read more »

Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanFor an industry that saves millions of lives, pharma is sometimes unfairly perceived by the public as being aloof, unresponsive, or occasionally worse. People outside the sector rarely appreciate the difficulty and cost of bringing new drugs to market, particularly when it comes to rolling them out in emerging global markets such as China, India and Africa.

Although globalization offers the prospect of vastly expanding the market for pharmaceuticals, grasping that opportunity is easier said than done. For a start, firms must ensure they understand and comply with a plethora of ever-changing regulation that varies from country to country. They generally need to liaise with hospitals and other medical and regulatory bodies to conduct country-specific clinical trials, even where a drug has been tested and approved elsewhere. And they may also have to contend with differing cultural attitudes to Western medicine that require them to tailor their marketing efforts accordingly. Read more »

Preparing for Regulatory Inspections

Patricia Van Arnum PharmTech editorRegulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). Pharmaceutical Technology will present an educational webcast on Thursday Nov. 7th from 1:00 to 2:00 PM EST, “Ensuring Preparedness for Regulatory Inspections,” which will provide insight on inspection trends and practical advice on how to best prepare for GCP/GMP inspections, examine the key information/documentation sought by regulators, and ways to achieve operational efficiency for providing access to that information. Read more »

Key Ways for Ensuring Global Regulatory Compliance

Patricia Van Arnum PharmTech editor International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance. Optimizing a quality management system to ensure regulatory and corporate compliance for product registrations for new and existing drugs in new geographic markets is essential for commercial success. Pharmaceutical Technology will examine the operational, organizational, and technological-based requirements on how to reduce risk and achieve operational efficiency for global product registrations in a live webcast on Tuesday June 11 from 2:00 to 3:00 PM EST. Read more »

A Call to Integrate Technology Innovation and Healthcare

In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release. Read more »

Social Media and the Pharma Industry

PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry. In his editorial, Mr. Davidson points to FDA and a lack of regulatory guidance as the reasons that social media has not caught on in the pharma and bio/pharma industries. FDA’s requirement to provide consumers with FDA-approved promotional materials that contain risk information may limit a pharmaceutical company’s ability to use mediums such as Twitter and Facebook effectively.

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Microchips and Video Games: Innovations in Healthcare

Stephanie Sutton Pharm Tech EuropeOnce upon a time in the world of healthcare, the only competition for a pharmaceutical company was other pharmaceutical companies.

Times have changed. Pharma companies are now competing with many nontraditional players in the healthcare arena, including electronic and mobile health firms, retailers, financial services companies and IT firms. Healthcare is no longer about just making a new medicine, but about creating greater value for patients, providers and payers, and encouraging a more active and healthy lifestyle.

In PharmTech, we often talk about manufacturing innovations, such as new dosage forms or more efficient manufacturing techniques, but today I’m going to look at some of the innovations that have been made in the healthcare industry as a whole. Read more »

Changing Trends in Laboratory Compliance

Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.

Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand here.

How Post-Market Feedback Can Influence Compliance when Using a Quality Management System

Guest blog by Tim Lozier.

In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback—whether positive or negative—and react to it. This is especially true with Quality Management Systems (QMS).

In today’s dynamic and demand-driven world, businesses are challenged with speeding their product-to-market strategies to remain competitive. In the pharmaceutical industry, regulatory and compliance pressure add another dimension to the QMS. Organizations want to bring their products to market quickly, but need to ensure quality and compliance standards are met—it’s a paradox of “hurry up, but take your time doing so.” Read more »

Pharma’s First Facebook Game

Stephanie Sutton Pharm Tech EuropeThis morning I received a press invitation from Boehringer Ingelheim for the beta launch of its Facebook game, Syrum. The game is the first of its kind to be developed by a pharmaceutical company. Syrum’s website is already up for people to view but the game won’t be officially launched until September. Read more »

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