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Top Tips – Building your ISO Quality Management System

Top tips for building your ISO Quality Management System for Pharmaceutical Companies A Quality Management System (QMS) is key for pharma companies and should encourage organisations to comply with ICH Q10 and ISO guidance. Pharmaceutical QMS must also accommodate unique industry requirements to achieve core quality principles and other requirements by providing all the features […]

Importance of Patient Engagement and Empowerment for Pharma

Except for direct participation in clinical trials and post-approval activities such as disease education, patient involvement in the biopharmaceutical development process remains episodic and restricted. Although this is slowly changing, patient involvement at each step of a product lifecycle is not yet standard practice for most companies. WHY Engaging Patients is Key for Pharma’s Success […]

Connecting in the Digital Age

Connecting in the Digital Age How Pharmaceutical Companies Can Use Marketing Outreach to Better Engage with Global Consumers By Guillem Vidal, Welocalize Life Sciences, lifesciences.welocalize.com Most companies are stepping into the digital age when it comes to their marketing techniques and strategies, and pharmaceutical companies should be no different. For these companies to continue to […]

Why Too Many Clinical Trials Fail

By Julien Moussalli Market Expansion Lead at IQVIA (LinkedIn: https://www.linkedin.com/in/julien-moussalli-80010349/) A makeover of the $65 billion clinical trials market (1) is well overdue. According to the National Cancer Institute, in the U.S only, 1.7 million people have been newly diagnosed with cancer in 2018 (2). In the meantime, pharma companies are trying to recruit thousands […]

The digital game changers in pharma are not digital tools, but new aspirations

Patient centricity, agility and digital capabilities are now the focus of many pharmaceutical companies to evolve one of the must important industries of our era. Just read some recent articles to confirm big-pharma is perusing evolution for a greater good ignited by these themes: MSD | Novartis | AZ | AbbVie | Sanofi | Among others We all can agree that entertainment, information […]

Brexit Checklist for the Pharma Industry

by John Cahill Director/Snr Consultant, Quality and Compliance A disorderly Brexit is moving from a possibility to a probability. While governments pass last minute legislation over the month of March, it is encouraging to be part of a responsible industry that treats the threat to patients very seriously and has, according to our government officials, prepared very […]

How you can add value to your self-inspection programme

by Lorraine Lyons. Pharmaceutical Quality Consultant and Qualified Person (QP) with over 16 years’ experience in the Pharmaceutical Industry. Self-inspections support an organisation in accomplishing its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control and governance processes. Better self-inspection programmes should not only help ensure compliance and […]

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