Can the Regulators Keep Up with the Emerging Digitalisation in Laboratories?

Sep 24, 2018

Laboratories constitute an essential part of any pharmaceutical company, as they are usually where the history of the company began. Without the scientific research taking place in the laboratories, there would be no medicines to regulate, produce and distribute. Nadia Sara Adjal of NNIT examines the future outlook on digitalisation in laboratories, and why instrument validation documentation may not be accepted by regulators today. ...

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Imprecise Protection? Differing Attitudes of Global Patent Offices to Precision Medicine

Sep 24, 2018

While precision medicine is streaking ahead in its development and governments are willing to embrace the new treatment options it offers, patent offices are still lagging behind in the protection they can offer. Fran Salisbury of Mewburn Ellis examines the differing attitudes of global patent offices to precision medicine, and considers what companies must be aware of in seeking to protect their IP. ...

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EU Falsified Medicines Directive: The Requirements

Sep 24, 2018

Manufacturers of pharmaceutical goods are required to identify all products with a 2D data matrix code and add tamper-evidence labelling. A much less forgiving verifier of data than the human eye, scanners operate on strict binary principles, which means even the slightest of cell corruption will result in rejection of the code. Bart Vansteenkiste, of Domino’s Global Life Sciences Sector, considers EU requirements and serialisation tactics. ...

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How to Develop Integrated Drug Delivery Systems to Meet Patient Needs

Sep 24, 2018

The field of integrated drug delivery is rapidly changing. Today’s patients are empowered, knowledgeable and seeking treatment on their own terms, often outside of healthcare settings. As the pharmaceutical and biopharmaceutical industries, along with their drug development and delivery partners, respond to this shift, they also need to comply with tightening regulations aimed at improving the quality and safety of increasingly complex drugs. Tibor Hlobik of West Pharmaceutical Services Inc looks into partnering for patients. ...

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A Placebo-controlled Clinical Study to Evaluate the Efficacy & Safety of Instavit® Sweet Dreams Oral Spray in the Treatment of Occasional Sleeplessness

Sep 24, 2018

New Instavit® Sweet Dreams is a melatonin-based oral spray supplement that has been physician-formulated. It is designed to promote a natural sleep cycle and a soothing night’s sleep with just two sprays. Dr Harisha S, ICBio Clinical Research PVT. Ltd, presents a study that evaluates the spray’s safety and efficacy in the treatment of occasional sleeplessness, finding improvement in patients with sleeping disorders with no serious adverse events observed. ...

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