Pharma Focus Asia Magazine

Foreword

Electronic Document Management

Mandate from May 2017

Pharmaceutical regulators are becoming more cautious about approving innovative medicines for consumers safety The US Food and Drug Administration FDA has established many regulations that govern the development testing and production processes of dr..

Strategy

Four Switches of Success

Very similar firms often achieve very different results This is explained by their genetic switches..

The Future of Pharma Regulations

The future of pharma regulations is challenging with diverse and complex regulations globally It will be challenging for industry to adapt to regulated and semiregulated markets alike while attempting to develop a harmonised strategy with evergrowing..

Rigour or Rigmarole

All companies plan to succeed but only a few succeed in planning The differences between them lie in how they answer seven fundamental questions..

Research & Development

Drug Development

A question-based process

Drug development is a complex time consuming and expensive process involving numerous stakeholders activities and regulatory authorities Broadly it can be classified in six steps starting from identification of lead molecule till submission of report..

Manufacturing

Immunogenicity of Protein Biotherapeutics

All protein biotherapeutics are potentially immunogenic and hence could elicit immunogenicity response These responses could be of different types such as binding antibodies or neutralising antibodies Immunogenicity of protein biotherapeutics is a ma..

Information Technology

Cost effective Data Operations

The need for an E2E data standards ecosystem

Successful organisations need to modify reactive operating model and develop an E2E data standards ecosystem with a different organisational structure..

Electronic FDA Submissions

Is APAC prepared for the 2017 mandate?

If your time to you is worth savin then you better start swimmin or youll sink like a stone for the times they are a changin Bob Dylan..

Expert Talk

Pushing the Limits of Temperature Control

Transforming packaging perceptions

Todays pharmaceutical environment has become increasingly complex with more specialty products like biologics injectable and clinical trial drugs being shipped than ever The industry standard for commercial packaging is 120 hours which is no longer a..

Biologics’ Drug Delivery Systems

In this interview Peter Soelkner of Vetter discusses drug delivery trends for biologics and in particular prefilled syringes He offers insight into the advantages and challenges of this system for biologics important issues to consider upfront and ta..

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