Philip Ward is ACT's European editor, phone +44 1244 538583, email@example.com
Investigators’ Financial Ties Come Under Close Scrutiny
Study finds that financial links between researchers and drug manufacturers are independently associated with positive trial results.
Novo Nordisk Invests $144 million in U.K. Diabetes Facility
As part of its collaboration on type 2 diabetes with the University of Oxford in the U.K., Novo Nordisk is investing 1 billion Danish kroner over the next 10 years in a new research center.
EMA Issues Summary of 2016 Highlights
The EMA has published a four-page document to summarize its main achievements relating to marketing authorizations of new medicines and the safety monitoring of authorized medicines during the past year.
Cancer Research UK Joins ACRP Standards Group
Cancer Research UK has become a member of the Workforce Development Steering Committee of the Association of Clinical Research Professionals (ACRP).
EMA Admits Brexit May Cause Significant Disruption
Guido Rasi, Executive Director of the European Medicines Agency, has conceded that the planned exit of the U.K. from the European Union could have a major impact on the activities of the EMA.
EMA Reveals Initiative on New Biosimilars
The European Medicines Agency will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.
Norway Tops Global Survey of Staff Turnover in CROs
Spare a thought for your Scandinavian colleagues who are running CROs
ICH Approves GCP Guideline Amendment
The Council adopts revision encouraging sponsors to implement improved oversight and management of clinical trials.
Design of Early-Stage Trials Can Bring Success in CNS Disorders
Finding and implementing an appropriate design for early-stage clinical trials is critical to the future success of medicines for central nervous system (CNS) disorders, according to new analysis from the European Medicines Agency (EMA)
EMA Issues Update on First-in-Human Trials Guideline
The European Medicines Agency (EMA) has released an update on its plans to revise the existing guideline on first-in-human clinical trials.
EUPATI Prepares to Celebrate 5th Anniversary in Brussels
EUPATI celebrates its 5th Anniversary in Brussels by staging a free workshop.
DIA Unveils Co-Chairs of 2017 EuroMeeting in Glasgow
The Drug Information Association (DIA) has released a video to introduce the two chairpersons of its 2017 EuroMeeting, to be held in Glasgow, U.K., from March 29-31
Clinical Research Grows in England
The new Research Activity League Table from the NIHR Clinical Research Network shows all NHS trusts or hospital groups in England are delivering clinical research and over 60% increased their research activity last year.
EMA Gives Open Access to Clinical Data on New Medicines
The EMA has adopted a new policy to give open access to clinical reports for new medicines for human use authorized in the EU.
Europe’s New Clinical Trials Landscape Looms Large
The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.
Calvo Elected for Second Term at EMA
Dr. Gonzalo Calvo has been re-elected by the Healthcare Professionals’ Working Party (HCPWP) of the European Medicines Agency (EMA) as its co-chair.
Richard Bergström Quits EFPIA
The director general leaves his position at the European Federation of Pharmaceutical Industries and Associations (EFPIA) after five years to pursue “a fresh challenge.”
Tribunal Orders Release of Withheld Data from London Trial
The tribunal noted the "strong public interest in releasing the data given the continued academic interest" and "the seeming reluctance for Queen Mary University to engage with other academics they thought were seeking to challenge their findings."
ICH GCP Guideline ‘Can Stay Relevant for 20 Years’
A statement issued by the European Forum for GCP (EFGCP) states that provided further updates are made, the ICH guideline for Good Clinical Practice (E6) can stay relevant for another 20 years.
EMA Develops Strategy on Adaptive Pathways
The EMA has published a final report about its pilot project on adaptive pathways. The results of the project showed that adaptive pathways can bring together regulators, HTA bodies, healthcare professionals and patients to agree on plans to generate data on a medicine in areas of unmet medical need.
EMA’s Future Location Remains in Doubt After Brexit Vote
The uncertainty surrounding where the agency and its 890-member staff will call home next may linger for months, if not years.
EMA Seeks to Revise Guidance on First-In-Human Trials
The European Medicines Agency (EMA) is proposing changes to the current guidelines on first-in-human clinical trials to improve risk-based strategies. This proposal was made with cooperation from the European Commission and the Member States of the European Union (EU).
EMA Issues Statement on Brexit
The agency offers its official comment following the UK's historic vote last week to leave the European Union.
Brexit Result Creates Huge Uncertainty for EMA, Drug Developers
Britain's unprecedented vote to leave the European Union will have major ramifications for the biopharma industry, including in areas such as drug regulation, R&D, IP rights, and market access.
EFGCP Renews Campaign on Older People in Research
European forum tackles the problem of limited elderly patients involved in clinical trials.
Oncologists Oppose Brexit, but Criticize EU Directive
With Britain’s potential succession from the EU looming, scientific leaders in Europe are voicing their concerns that losing the UK would be a blow to clinical research.
EFGCP Steps Up Campaign to Include Older People
The Geriatric Medicines Working Party of the EFGCP is organizing a workshop on “Technology, Ethics and Older People in Clinical Research.” The goal is to explore what can be done to involve older people in clinical trials.
EMA Releases New Advice on Human Trials for Cancer Drugs
The agency is concerned about the lack of non-clinical models with good predictive properties in the oncology space.
CISCRP Links Up With Euro Groups on Patient Education
The Center for Information and Study on Clinical Research Participation is launching its first international event, where in Europe, CISCRP says, patient involvement in clinical trials is waning and general awareness about research opportunities is low.
Fresh Doubts Cast on Reporting of Results by Top Academic Centers
Research group finds that only 29% of completed clinical trials at major U.S. academic centers were published within two years of completion.
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