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 …

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 …

Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production

Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production

At BioPharma India Convention 2014, Samuel Raj Solomon, PhD., RAC (US & EU) Sr. Manager & Head -Biosimilars Regulatory Sciences, Biocon Ltd. India presented on the topic : Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production. Download the presentation to learn: Central Dogma Of Biosimilars Manufacturing Regulatory Compliance For Biosimilars Manufacturing Systematic Risk And Science Based Approach – CQA Hallmarks Of Pivotal CMC …

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 …

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 …

Compliance and internal controls: Bringing the two worlds together

Anna Giedrys, Head Global Compliance and Control Development, Novartis Business Services, gave the presentation “Compliance and Internal Controls: Bringing the two worlds together” at last year’s Pharma Engagement Live event. Download and Learn: Development control matrix Simply complexity Control activity References DCM self assessment Control maturity level DCM the results 2 years on Download Presentation Found this interesting? You might …

Collaboration between Internal Audit and Compliance

At last year’s Pharma Compliance Europe event, Peter Elam, Head of Internal Audit, Novartis, gave the presentation “Collaboration between Internal Audit and Compliance.” Download and learn: Global Novartis compliance framework Risk assdessment and monitoring Reversing the “Three Lines of Defense” Progression in relationship between functions Download Presentation Found this interesting? You might also be interested in our Pharma Compliance Europe …

EFPIA/HCP/HCO transfer of value disclosure requirements: Implementation and challenges within a multi national company

Dr Marcel Koerting, Senior legal and Compliance Council, Novo Noridsk Healthcare AG, gave the presentation “EFPIA/HCP/HCO transfer of value disclosure requirements: Implementation and challenges within a multi national company” at last year’s Pharma Compliance Europe event. Download and learn: Novo Nordisk overview EFPIA disclosure code Key challenges Download Presentation Found this interesting? You might also be interested in our Pharma Compliance Europe …

Taking control of your global compliance ecosystem

At last year’s Pharma Compliance 2014 event, Greg Maynard, Director, Transparency and Disclosure Solutions, Health Market Science, gave a presentation “Taking control of your global compliance ecosystem.” Download and learn: Elements of a global transparency program Data Sourcing Data management Recipient profile data privacy data governing reporting Download Presentation Found this interesting? You might also be interested in our Pharma …

Developing clear and structured monitoring strategies that minimise risks and optimise compliance success rates.

Last year at the Pharma Compliance Europe 2014 event, Karolina Czernicka-Kuhl,  Head of Legal and Compliance, Novo Nordisk, gave the presentation “Developing clear and structured monitoring strategies that minimise risks and optimise compliance success rates.” Download and learn: Why monitoring? What should be monitored? How to monitor (who should monitor)? Benefits and costs Download Presentation Found this interesting? You might also …