Search Results for IQWiG

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Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

German Regulators Decry Lack of Trial Transparency in Look at Stem Cell Transplantation By Michael Mezher - Published 01 May 2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has found recent clinical data on the use of stem cell transplantation to treat multiple myeloma—a rare and deadly form of cancer—to be inconclusive.

Categories: News, Europe, Blood, Clinical, Drugs, Human cell and tissue

Tags: IQWiG, Stem cell transplantation, multiple myeloma, Federal Joint Committee, G-BA

Study Claims German Dossier Requirements Could Improve Open Access to Trial Data By Michael Mezher - Published 03 March 2015

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

Categories: News, Europe, EMA, Clinical, Ethics, Government affairs, Regulatory strategy, Reimbursement, Submission and registration

Tags: IQWiG, Health Technology Assessment, AMNOG, Clinical Trial Transparency

German Regulator Says EMA's Clinical Trials Transparency Definitions are Too Broad By Louise Zornoza, RegLink News - Published 27 February 2015

German health technology assessment body IQWiG has criticized the European Medicines Agency's (EMA) clinical trials data transparency implementation plan, saying its definition of commercially confidential information is overly broad.

Categories: News, US, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: Germany, RegLink, IQWiG, Clinical Trials Transparency

German Price Watchdog Says ‘No’ to 3 Cancer Drugs By Michael Mezher - Published 23 January 2015

The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month.

Categories: News, Europe, Clinical, Prescription drugs, Reimbursement

Tags: IQWiG, Health Technology Assessment, HTA, G-BA, Federal Joint Committee, AMNOG

IQWiG Finds Important Information Missing in Most Publications, Calls for CSR Disclosures By Louise Zornoza, RegLink - Published 10 October 2013

Tags: IQWiG, Germany

Germany’s IQWiG Declines to Recommend Shire’s Elvanse for ADHD By Louise Zornoza, RegLink - Published 05 September 2013

Tags: IQWiG, Germany, Shire

Germany’s IQWiG Declines to Recommend Linaclotide for Irritable Bowel Syndrome By Louise Zornoza, RegLink - Published 08 August 2013

Tags: IBS, IQWiG, Germany

Germany: IQWiG Recommends Combination Rilpivirine for HIV By Louise Zornoza, RegLink - Published 06 July 2012

Categories: Regulatory Update

Tags: Coverage Decision, Reverse, IQWiG, Germany, HIV, HTA, CER

Germany: IQWiG Finds Melanoma Drug Extends Life By Louise Zornoza, RegLink - Published 03 May 2012

Categories: Regulatory Update

Tags: IQWiG, Germany, ipilimumab, HTA, CER