Pharma white papers on contemporary issues, technologies, research, etc. are presented in this section to enable the readers with rich information and knowledge. This section provides white papers related to all the spheres of the pharma industry.
Traditionally complexity in clinical trials is translated into increased operational challenges due to the presence of several IMPs populations trial sites multiple sponsors andor manufacturers and contract research organizations CROs
Drug development requires an average overall investment of USD billion and remains at high risk due to the huge attrition rate phase after phase The preclinical development phase and the phase clinical trial show the highest attrition rate due to toxicity or drug metabolism pharmacokinetic issues Mitigating the risk during a new drug candidate development program starting from the discove...
When COVID disrupted life sciences solutions were needed in realtime As the pandemic grew so did the need to innovate Workers met the challenges They completed tasks fulfilled inspections and remained vigilant in fulfilling regulatory requirements This paper presents findings from a roundtable hosted by PharmaLex
After more than three decades of fast economic growth China has entered the new normal stage marked by a moderate and stable domestic GDP growth rate Healthcare has been elevated to a national level agenda by the current leadership with the releasing of China Health
SummaryThe target market for conducting global clinical trials has changed significantly moving beyond pharmaceutical early adopters to the mainstream marketplace This shift has placed a heightened focus on the language challenges and complexity of running a global clinical trialMore and more companies are moving toward
SummaryValidation of Pure Steam and the verification of the final aqueous rinse in a CIP process are defined by regulatory standards which change periodically and challenge system designers and owners to know the latest requirements This white paper contains an overview of current pharmacopeia requirements which will assist in the design and monitoring of comp
SummaryRandomized doubleblind clinical trials are the gold standard for adequate and wellcontrolled studies in modern times However prior to the late s randomization and blinding were not used in medicine and as result bias was common For example treatment bias was often observed as physicians would treat sicker patients with known controls while
SummaryThis white paper will explore current trends related to procurement and sourcing is evolving role in the supplier discovery process and current practices for accessing supplier information It will explore the ability of new technology to enable procurement and sourcing professionals to reduce the time spent identifying qualified suppliers prior to initiating the RFP process Finally
SummarySerialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another Several countries including China South Korea Turkey Argentina and Brazil already have regulations in place that must be complied with whilst many others including countries i
SummaryEvery business faces risk Broadly speaking the primary categories of business risk are Market Financial Execution and Regulatory Successful companies have developed a core competency in managing for these risks turning risk management into a sustainable competitive advantage For drug manufacturers recent trends have underscored the importance o
