Pharma Focus Asia

Previous Issue - Issue 30

This Pharma Magazine is the source for a plethora of unique Pharma articles. Several notable figures from top pharma organisations are featured in the R&D, Manufacturing and Clinical Trials sections, with their expert knowledge of the field.

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Issue 30 | 2018

Issue 30

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Foreword

Continuous Employee Screening in Pharma Industry

The new normal?

Continuous screening provides employers with a valuable tool to best evaluate their risks and ensure they place their employees in the most appropriate positions Lucia BonePerforming background verification or screening of new hires has been a practice the world over to ensure the organisation employs individuals that are talented and skilful a...

Strategy

Setting up a Pharmacovigilance System

Pharmacovigilance PV is principally concerned with the identification of Adverse Drug Reactions ADRs and reduction of the associated risks Detection and reporting of ADRs can make prescription of medicinal products much safer and more effective This is possible only if pharmaceutical companies and patients report the ADRs as and when they occur...

Biosimilars Interchangeability

Regional views aren’t interchangeable

Around the world regulators view biosimilars rather differently in terms of designating them as interchangeable with the reference product To date the US has taken a conservative approach not with standing the experience Europe has gained in monitoring thousands of patients who have switched from originator to biosimilar products Meanwhile in Asia...

The Importance of Post-Hire Screening in the Pharmaceutical Industry

Preemployment background checks are generally wellaccepted as part of the hiring process in highlyregulated sectors such as the pharmaceutical industry With patents and other valuable intellectual propertyoften worth millionsat risk the potential of sabotage from activist groups theft from industry rivals potential insider threats and not to forget...

The Evolution of Brand Strategy

As the pharmaceutical market transforms, so does the meaning of brand strategy

Imagine being a fly on the wall when I conduct one of my research interviews in a pharmaceutical medtech or diagnostic company Observe what happens when I ask one of my carefully worded questions Please describe your brand strategy Since I research across many countries and disease areas the answers vary in detail But witness enough interviews and...

Research & Development

Reaching a New Innovation Threshold

How can we make it happen?

The difficulty of getting reimbursement in the US for novel therapeutics especially ones based on innovative new technology platforms renders such products less available in AsiaPacific as well Fully half of new active substances NASs approved globally each year ownership of the extant RD pipeline worldwide and the endmarket for all medicines are i...

Clinical Trials

Managing Clinical-Trial Agreements

Clinical Trial agreements are an essential GCP document and are integral to achieving clinical trial success They define the legal relationship between sponsors Clinical Research Organisations CRO and sites and establish the rules under which the clinical trial will be conducted There are several key criteria which determine whether a Clinical Tria...

Manufacturing

Safe and Secure

Packaging\\\'s role in combating counterfeit drugs

According to data released by the United States Food and Drug Administration USFDA approximately per cent of all pharmaceuticals sold globally are counterfeit Whilst counterfeiters are active around the world not all markets suffer equally Unsurprisingly the World Health Organization WHO reports that developed nations such Europe and the USA are...

Modelling and its Applications in Solids-based Continuous Pharmaceutical Manufacturing Processes

In recent years the pharmaceutical industry has been actively involved in exploring advanced manufacturing processes that can help reduce the manufacturing costs and improve the product quality One of the most promising route is the switch from batch to Continuous Pharmaceutical Manufacturing CPM processes The continuous production mode enables a s...

System Engineering for a Novel Continuous Pharmaceutical Manufacturing Process

Pharmaceutical industries as well as regulators eg FDA are strongly promoting smarter Continuous Manufacturing CM Few pharmaceutical products have been recently approved by US Food and Drug Administration FDA to manufacture in continuous line and several others are on the way There are several advantages but also different scientific challenges for...

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