Drug Development Consultant and Regulatory Consultant

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Twitter Weekly Updates for 2009-08-30

How to write a business plan fee e course launched! http://bit.ly/5O4T3 #
When looking at drug device combinations history has a number of lessons for us! #
Epidemiology can be established with grey data when the peer reviewed sources let you down! #

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Drug Regulators International Collaberation on GCP Inspections

The FDA and the EMEA will be sharing information on inspection planning, policy and outcomes and they will be colaborating on inspections

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Drug Regulators Publish Guidance on NAT testing to reduce the risk of Contamination of Plasma-Derived Products

The FDA, are issuing this guidance to provide you, manufacturers of plasma-derived products, with recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Such testing will identify and help to prevent the use of plasma units containing high levels of parvovirus B19. This guidance also recommends how to report to FDA implementation of parvovirus B19 NAT.

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Drug Regulators Publish Concept Paper on Clinical Investigations of Specific Immunoglobulins

Due to the recent increase of submission of marketing authorisation applications for human plasma-derived hepatitis B immunoglobulin (HBIG), several questions regarding the required clinical data arise. Furthermore, compliance to the current available Core SmPC being recommended, a specific guidance relating to the clinical investigation of HBIG products appears appropriate. The expansion of this NfG to all specific immunoglobulins needs to be considered.

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Draft Guidance Published by Drug Regulators on CE-marked Medical Devices – Neurostimulators

This guidance document gives advice to manufacturers on the notification of adverse incidents involving neurostimulators under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC.

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Twitter Weekly Updates for 2009-08-23

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Test your knowledge and asumptions, I did a routeen fact check and found a fundamental shift! Knowledge can go out of date overnight! #

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Drug Regulators Publish ICH consideration on Virus and Vector Shredding

For the purpose of this ICH Considerations document, shedding is defined as the issemination of the virus / vector through secretions and/or excreta of the patient.

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Drug Development Guidance – FDA publish Drug Induced Livery Injust Evaluation Guidance

FDA publishes Drug-Induced Liver Injury: Premarketing Clinical Evaluation Guidance; his guidance is intended to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

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Drug Regulators EMEA Publish Concept Paper on the Need to Revise the Guidlines on the use of Transgenic Animals in Biological Manufacture.

The EMEA has published the following “CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)”

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Drug Development Guidance – EMEA for Medical Products for Term and Preterm Neonates

EMEA publishes “GUIDELINE ON THE INVESTIGATION OF MEDICINAL PRODUCTS IN THE TERM AND PRETERM NEONATE”. This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.