Adis whitepaper

Whitepaper: The changing faces of device safety

The benefits of literature monitoring throughout the lifecycle Executive Summary One would be forgiven for thinking that the current changes to the guidelines for medical device safety meant just an increase in workload for the manufacturers. But look beyond the “overalls” and you will see that these changes present a golden opportunity for the device industry to demonstrate the real-world benefits it has on …

Zenith Serialisation Whitepaper

Overcoming the practical challenges of Pharmaceutical Serialization

Is Pharmaceutical Serialization on your radar? With new regulations either being implemented or pending should it be? Serialization entails adding a unique identifier to single saleable units of prescription and some other medicines so they can be tracked and authenticated throughout the supply chain. Requirements for serialization are already active in some parts of the world and they will be …

Drug Safety Europe 2016

Ensuring Compliance for Cloud: A Risk Management Guide for Life Sciences Organizations

In an effort to manage cost pressures, optimize operational efficiencies, and build robust IT capabilities, the life sciences industry is also shifting to the cloud. However, being a highly regulated industry, players face significant compliance challenges while leveraging the cloud. In addition to managing security risks in a shared computing environment, organizations also need to ensure that regulatory commitments are …

Abbot Laboratories Whitepaper

Whitepaper: Considerations in Purchasing a LIMS

Randy C. Hice | Abbot Laboratories Many scientific enterprises find themselves in need of a Laboratory Information Management System (LIMS) to replace an incumbent system, whether an existing commercial application, an amalgam of systems, or an in-house solution. Once the decision has been made, the selection and deployment of a new LIMS should move quickly and decisively. This white paper …

lexisnexis whitepaper

Download whitepaper – Pharmaceutical & Life sciences: Third Party Due Diligence

Whitepaper by LexisNexis Few industries are as exposed to risk as the pharmaceuticals and life sciences. It is no longer enough to carry out basic checks alone on third-parties. Companies must engage in enhanced due diligence if they are to avoid the large fines and regulatory penalties. Effective third-party due diligence is increasingly recognized as a strategic driver for sustainable …

MMM and Oracle webcast

Applying Technologies Across the End-to-End PV Process to Increase Compliance and Quality

29 Oct 2015 Andrew Rut, Chief Executive Officer, MyMeds&Me Michael Braun-Boghos, Director of Safety Analytics, Oracle Health Sciences Safe Harbor Statement The following is intended to outline MyMeds&Me and Oracle Health Sciences  general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or …

quality control, QA, quality assurance, QA, QC, manufacturing, efficiency

Download: QA, QC practices in manufacturing to ensure efficiency & quality

Dr Pradeep Nagalkar, Head Quality Control (Bio. & Chem.), Haffkine Bio-Pharma. Corp. Ltd., Mumbai gave a presentation on QA, QC Practices in Manufacturing to Ensure Efficiency & Quality at BioPharma India Convention 2014. Download the presentation to learn: What is Quality Control Importance of Quality Control in Biopharmaceutical Industry Advantages of Quality Control What is Quality Assurance (QA) What is the difference between …

Tata Consultancy Services whitepaper

Managing Regulatory Compliance in the Pharmaceutical Industry

Changes in regulation, alongside the introduction of stringent anti-corruption legislation, are forcing pharmaceutical companies to renew their focus on compliance. Globally, pharma organizations have to embrace a holistic approach. This involves aligning complex and disparate risks and regulatory compliance activities to the overall corporate strategy. The Increased Risks in Regulatory Compliance The pharmaceutical industry is coming under increased scrutiny across …

IP, protection, IP protection, India, CDMO, IPR, intellectual property,

India on the radar for CDMO services

Prof. Dr. Rolf G. Werner, Professorship for Industrial Biotechnology, Eberhard Karls University of Tuebingen, Germany gave an in-depth presentation at last year’s BioPharma India Convention 2014 on CDMO services in India. In his presentation, Dr Werner covered: Intellectual property in India (pharma products) Current IPR regime in India Current India data protection regime Internal measures at CDMO Download presentation As IP …

Algorics

Press- release: Algorics releases latest version of its acuity solution

Houston, TX, USA, For Release: 5th August 2015. Algorics, a provider of clinical analytics solutions and software for the global life sciences industry, today announced the release of the latest version of its acuity solution – designed for use by pharma, biotech, CRO and academic organizations to drive regulatory compliant processes around management of risk. The acuity solution allows organizations …