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EMA supports regulatory harmonisation in East Africa

EMA supports regulatory harmonisation in East Africa East African Community (EAC) envisages the creation of regional regulatory entity As part of the European Medicines Agency's (EMA) ongoing collaboration with African regulators, a delegation of Heads of Agencies from the East African CommunityExternal link icon (EAC) visited EMA to gather information on the structure and operations of EMA. The meeting that took place on 18/19 May 2017 aimed at exploring whether EMA could serve as a model for the potential creation of a regional medicines agency for the EAC. The report about the visit published by EMA and EAC states that, in addition to engaging in other international activities, the establishment of an EAC regional structure is important to sustain the ongoing joint regulatory harmonisation activities. The group also identified the main steps needed to establish such an agency. The benchmarking study visit concluded that there is political will and a strong commitment of regulators from the EAC to improve public health by ensuring citizens have access to affordable, safe, efficacious and quality medicines. The EAC is composed of six countries: Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda. The delegation that visited EMA in May included the Heads of the national agencies, the EAC Secretariat, and representatives from the World Health Organization (WHO) and the World Bank GroupExternal link icon..

The top prize was awarded to a project that discovered a potential new treatment for paediatric leukemia. That project will receive the Herbert Pardes Clinical Research Excellence Award, named for the executive vice chair of New York-Presbyterian Hospital’s Board of Trustees and the hospital’s former president and chief executive officer, a physician who is regarded as a champion and visionary in clinical research.

SCRS launches Site Advocacy Group to promote sustainable research

The Society for Clinical Research Sites (SCRS) is proud to announce the launch of its newest initiative, the Site Advocacy Group (SAG).  SCRS is honored to have TransCelerate BioPharma Inc. (“TransCelerate”) as its SAG partner.

The SAG is a landmark industry initiative that enables clinical investigators and site professionals to interact directly with senior industry leaders in the exchange of perspectives and experiences on innovative ideas, processes, tools and technologies.  The knowledge gained will help to promote site sustainability, enhance clinical research effectiveness and more closely align the work of the sites and industry across the research ecosystem.

“By bringing together the global site community, SCRS has actively advocated for the sustainability of all sites.  The formation of the SAG is the most recent example,” stated Christine Pierre, President of the Society for Clinical Research Sites. “It marks a true coalescence of major industry stakeholders working together towards mutually beneficial and respectful outcomes with the sites. This commitment by TransCelerate, representing 19 major sponsors, demonstrates a true commitment to the site community through SCRS’ SAG.”

Survey shows that CRO salaries continue to rise

A recent study by HR+ Survey Solutions reveals that merit increase budgets are on the rise in the Global CRO industry. The study found that while the highest reported salary increase budget across the globe for 2013 was 21%, that figure rose to 25% for 2014. The country with the highest average budgeted increase is Argentina with an average increase of 16.1% for 2014. The country with the lowest average budget increase is Portugal with an average increase budget of only 1.8%. This compares to the overall global average budgeted increase for 2014 of 4.1%.

The survey also found that while sixty-percent (60%) of the actual increases for 2013 were less than budgeted, by an average of 0.3%, interestingly, 60% of the budgeted increases for 2014 are larger than actual increases in 2013 by 0.4% The study provides information about planned increases vs actual increases, industry budgets vs global budgets and covered 52 countries globally.
Other findings include:

  • The country reporting the largest budget increase from 2013 to 2014 was Indonesia, with an average planned increase that was up 3% from last year.
  • The average budgeted increase for the US is 3% for 2014 which is in line with general industry. Most surveys are projecting 2014 salary increase budgets to hover around 3%

Quintiles & Biogen Idec begin strategic partnership

Quintiles and Biogen Idec have announced that they have entered into a five-year strategic clinical development agreement. The multi-year collaboration is designed to leverage the expertise and experience from both organizations to optimize Biogen Idec’s clinical development processes.

The collaboration is structured to increase clinical trial efficiency, with a focus on transparency, quality, innovation and operational excellence. Under the agreement, a dedicated team from Quintiles will work with Biogen Idec on the design, planning and execution of Biogen Idec’s phase II-IV studies and select phase I studies. In addition, Biogen Idec will leverage Quintiles’ technology and systems across its growing portfolio.

The collaboration is already underway. New projects are being initiated through the collaboration, and several of Biogen Idec’s ongoing studies are currently transitioning to Quintiles.

 

 

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