Attitudes on global clinical trials

Download eBook: Key factors surrounding the growth in global clinical trials

Clinicaltrials.gov indicates that more than half of clinical trials are being conducted outside the United States in developing countries, and that number is expected to grow. Why the dramatic change in acceptance of global clinical trials? Lionbridge Life Sciences had an opportunity to hear directly from many respected members of the Drug Information Association (DIA) at their 2014 Annual Meeting …

Implementing an Enterprise Wide LMS

Some time back, not too long ago, the North American headquarters of a global Pharmaceutical company acquired several business units, and in an effort to standardize roles and consolidate training and qualifications, company leaders were seeking a single Learning Management System (LMS) to unify its eight operating companies and 7,000 employees. Leading the LMS evaluation were members of the Information …

Private Cord Blood Banks vs Public Health: Is it Time to Bury the Hatchet?

Can private cord blood banks ever work in synergy with public and national health services? Cord blood is the blood that remains in the placenta and umbilical cord after a baby is born. It is rich in stem cells, which can help to cure many life threatening diseases. The stem cells found in cord blood restore the function of the …

Enterprise Risk Management: Implementation challenges & a practical approach

  At last year’s Pharma Compliance Europe event, Bernard Fourie, Director Internal Control & Risk Monitoring, Ferring Pharmaceuticals gave a presentation on “Enterprise Risk Management: Implementation challenges & a practical approach” Download the presentation to learn: Defining ERM in Pharma Identify implementation challenges and potential solutions Back to basics: Practical first steps and a potential roadmap Critical Success Factors Download presentation …

Stemming The Flow Of Precursor Chemicals from India

  According to the 2010 International Narcotics Control Board (INCB) annual report, India is now the major source of diverted precursor chemicals. These chemicals are vital ingredients in the manufacture of narcotics such as amphetamine-type stimulants (ATS), methamphetamine, heroin and cocaine. The control of precursor chemicals is increasingly fundamental to the war against drugs. While precursor control was included in the United Nations 1988 Convention against the Illicit …

Regulatory updates on Cellular & Tissue-based Products in Japan

Masakazu Hirata, MD, PhD, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA) joined us at the 9th Annual World Stem Cells & Regenerative Medicine Congress to present on ‘Regulatory updates on Cellular & Tissue-based Products in Japan.’ Download this presentation now to find out: Who are the PMDA? Regulatory Authorities in Japan Government’s Policy: Regenerative Medicine …

Download: Delivering effective training on compliance

Dr. Britta Luescher, Compliance Director, Novartis International AG, Switzerland gave a presentation at Pharma Compliance Europe 2013 on “Delivering effective training on compliance-Implementing a comprehensive training and monitoring system”. Download the presentation to learn: Delivering effective compliance training Training as part of a comprehensive compliance system What are the considerations for delivering effective compliance training? Consistency: Consider training as promoting a …

Streamlining phase I to phase III to gain regulatory and reimbursement approval

María Pascual, VP ClinOps & Regulatory Affairs, TiGenix joined us at the 9th Annual World Stem Cells & Regenerative Medicine Congress to present on ‘Streamlining phase I to phase III to receive regulatory and reimbursement approval.’ Download this presentation now to find out: ChondroCelect® casestudy – First approved ATMP in Europe eASCs General Challenges with ATMPs What Pharma sees as …