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Deadly Anti-Vaxxers

The WHO lists ‘vaccine hesitancy’ among the 10 greatest threats to global health in 2019; unfounded fears are endangering health. Writing in Nature, Heidi Larson, a professor at the London School of Hygiene and Tropical Medicine, UK, predicted that the next pandemic would spread not for lack of preventative technologies, but rather because “emotional contagion, digitally enabled, could erode trust in vaccines so much as to render them moot.” According to Heidi, modern internet culture has played a significant role in stoking fear of vaccinations and, in a social media environment that is emotionally volatile, encourages snap judgement, and is mistrustful of elites and authority, misinformation spreads more easily.

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Dr Graham Hughes
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Northway Biotechpharma enters into Development and Manufacturing Agreement with Synklino

Vilnius, Lithuania, and Copenhagen, Denmark – December 18th 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Synklino, a company active in developing a therapeutic protein based therapy as treatment for cytomegalovirus (CMV) infection, announced today that they entered into a Development and Manufacturing Agreement for the recombinant fusion protein SYNx, which Synklino aims to bring into clinical trials.
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Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
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