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 …

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 …

Clinical trials, Lionbridge Life Sciences, Life Science, Regulatory, Translations, Global communications

Efficient, Flawless Clinical Trial Translations

Successful global clinical trials require early consideration of the costs, complexities, and risks of communications. Best practices for clinical trials translation ensure your global trials are efficient, cost-effective, and successful in all markets. Language is a mission-critical element toward both culturally and regulatory-appropriate content contained in all forms of communication associated with clinical trials. Download our Clinical Trials Solution Brief to learn …

obstacles, global development, biosimilars

Regulatory provisions as facilitation and obstacles to global development of biosimilars

At the Biosimilar Drug Development World Europe event 2014, Andrea Laslop, AGES PharmMed gave a presentation on “Regulatory provisions as facilitation and obstacles to global development of biosimilars” Download and learn: Biosimilar regulation in EU Biosimilar regulation/approvals in other regions Joint approaches – the biosimilar “cluster“ Summary Download Presentation Found this interesting? Join us at next year’s Biosimilar Drug Development …

stem cells

‘Manipulated’ Stem Cells: How iPSCs have gone from Nobel Prize research to novel therapy reality

First patient to receive induced pluripotent stem cells in Japan to treat macular degeneration – is this a result of their regulatory modifications?   2006 saw the discovery that normal human adult cells could be ‘reprogrammed’ to become stem cells that could adopt the form of any type of cell, from heart to liver to skin. Fast-forward to this decade …

Overview of early scientific advice for HTA- regulatory interactions

  At Health Technology Assessment World Europe 2012, Franz Pichler, Advisor, Global Public Policy, Eli Lilly and Co-chair, HTAi Interest Sub Group on HTA-Regulatory Interactions gave a presentation focusing on the overview of early scientific advice for HTA- regulatory interactions. Download this presentation and learn: How regulatory scientific advice impacts outcome Early scientific advice HTA-Regulatory interaction Parallel advice- what is …

5 Top reasons why clinical research is moving to Latin America

Latin America: With the rise of intense global competition, pharmaceutical companies are under increasing pressure to develop and introduce novel therapies as quickly as possible.  As the speed to market becomes increasingly important, the new drugs entering clinical development are faced with increasing competition for subjects and investigators in the key regions for clinical trials, including the US, Canada and …

Download: Regulatory perspective on EU Legislation, Mick Foy, MHRA

“Regulatory perspective on EU Legislation“ On 31 December 2010, the start of major changes to the EU’s pharmacovigilance legislation began, with significant challenges for the pharmaceutical industry and regulatory agencies. With the new laws being applied in July 2012, this year’s World Drug Safety Congress Europe conference will give an in-depth review of all the guidelines being put in place. …