Theorem Clinical Research

Ethics/Regulatory

Health Research Authority business plan approved to streamline research in U.K.

Wednesday, April 2, 2014 01:44 PM

The U.K. Department of Health has approved the Health Research Authority (HRA) funding plans for HRA Assessment and Approval. This funding means the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.

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NICE seeks views on how it assesses drugs and other technologies for the NHS

Friday, March 28, 2014 03:15 PM

The National Institute for Health and Care Excellence (NICE) has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. NICE assesses the clinical and cost effectiveness of new technologies to help ensure patients have access to effective treatments and the NHS makes the best use of its resources.

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Chesapeake IRB acquires Goodwyn IRB

Thursday, March 27, 2014 09:39 AM

Chesapeake IRB has completed the acquisition of Goodwyn IRB.

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PHT launches FDA Roadmap App for patient-focused outcome measurement

Wednesday, March 26, 2014 11:44 AM

Launched by PHT, a provider of technologies used to collect patient-driven eData for clinical research, the new FDA Roadmap App is the first mobile app designed to help sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, released by the FDA in conjunction with its Clinical Outcome Assessment Qualification Program. The program and roadmap highlight the process by which a sponsor should consider, choose and/or develop a patient-focused outcome measurement strategy in a clinical program.

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European Medicines Agency launches adaptive licensing pilot project

Thursday, March 20, 2014 01:03 PM

The EMA is inviting companies to participate in its adaptive licensing pilot project. Interested companies should submit ongoing medicine development programs for consideration as prospective pilot cases.

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U.K. forms early access to medicines scheme

Monday, March 17, 2014 01:41 PM

The U.K. government has announced a new scheme that aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization.

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vfa CEO responds to German pharmaceutical policy changes

Monday, March 3, 2014 12:46 PM

The German Bundestag is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code, including an extension of the drug price freeze to 2017.

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U.S., India sign cooperation statement

Thursday, February 27, 2014 12:24 PM

According to the Press Information Bureau of the Indian government, the FDA and India’s Ministry of Health and Family Welfare have signed a Statement of Intent on Cooperation in the Field of Medical Products.

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EMA, FDA collaborate on medicines safety

Friday, February 21, 2014 03:31 PM

The EMA and FDA, which respectively regulate drugs in the E.U. and U.S., have announced a new pharmacovigilance “cluster” to provide a forum to share information on the safety of medicines.

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Regulatory update on India clinical research approval timelines

Wednesday, February 5, 2014 01:26 PM

Dr. Renu Razdan, vice president, ACRO India, and also chief operating officer, CRO Max Neeman Medical International, said he welcomes the new timelines and guidelines set up by the Drug Controller General of India [DCGI] for approval of clinical trials.

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