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Products In Regulatory Affairs (Total Products 24, Showing: 1 -> 20)

Animal materials and derivatives in medical devices Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Devices Manual and written by Brian Matthews, this expert review explores the potential issues which may arise from the use of animal materials and their derivatives. CLICK TO BUY ONLINE NOW! | Read full details

Balancing customer expectations with cGMP compliance Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Lynne Jones Batshon and first published in Journal of Generic Medicines, Volume 3, Number 2, January 2006 CLICK TO BUY ONLINE NOW! | Read full details

Combination of drug and device in needlefree injectors Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Devices Manual and written by Roger G Harrison, this expert review summarises some of the data that are currently available and will project the future applications and place of needle-free injection. CLICK TO BUY ONLINE NOW! | Read full details

Commentary: Bioequivalence, interchangeability and perceptions Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Jake J. Thiessen and first published in Journal of Generic Medicines, Volume 2, Number 3, April 2005 CLICK TO BUY ONLINE NOW! | Read full details

Constructing an immunogenicity risk assessment for follow-on biologics Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Paul Chamberlain and Anthony Mire-Sluis and first published in Journal of Generic Medicines, Volume 2, Number 2, January 2005 CLICK TO BUY ONLINE NOW! | Read full details

Creating eCTD applications Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Kim Nordfjeld and Vito Strasberger and first published in Journal of Generic Medicines, Volume 3, Number 2, January 2006 CLICK TO BUY ONLINE NOW! | Read full details

Drug master file review issues at the Office of Generic Drugs Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Paul Schwartz and first published in Journal of Generic Medicines, Volume 3, Number 4, July 2006 CLICK TO BUY ONLINE NOW! | Read full details

Drug regulation in the European Union Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Marketing Manual, John Griffin describes how the major thrust of European Legislation in the field of Drug Regulation is directed at harmonisation of marketing authorisation of medicinal products. CLICK TO BUY ONLINE NOW! | Read full details

Drug Safety for Marketed Drugs Published by KeywordPharma Our Price: £75.00 In-depth report from the eyeforpharma conference, Amsterdam, 22-23 November 2005. Edited by Martin Fagan. CLICK TO BUY ONLINE NOW! | Read full details

Generic biopharmaceuticals: Towards a science-based abbreviated process Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Gordon Johnston and first published in Journal of Generic Medicines, Volume 2, Number 2, January 2005 CLICK TO BUY ONLINE NOW! | Read full details

Impact of court cases on summary of product characteristics harmonisation Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Richard Milchior and first published in Journal of Generic Medicines, Volume 2, Number 3, April 2005 CLICK TO BUY ONLINE NOW! | Read full details

Medical Devices with a Measuring Function Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Devices Manual, this review written by David Adams describes how medical devices with a measuring function must provide sufficient accuracy and stability, particularly where patient safety is at risk. CLICK TO BUY ONLINE NOW! | Read full details

NICE and Medical Devices - all you need to know Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Devices Manual, this review written by Anne-Toni Rodgers provides invaluable information on the National Institute for Clinical Excellence (NICE), for manufacturers of medical devices. CLICK TO BUY ONLINE NOW! | Read full details

Other Directives (Drug, Cosmetics, Machinery, PPE, etc) Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Devices Manual, Grant Castle gives those involved in the development, manufacturing and marketing of medical devices an insight into some of the other European Community legislation that they might need to consider. CLICK TO BUY ONLINE NOW! | Read full details

Outcomes measures, evidence-based studies, the Cochrane Collaboration, prescribing support and NICE Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Marketing Manual, Ray Churnside explains that the efficacy, safety and quality of interventions are necessary but no longer sufficient conditions for their adoption in increasingly cost conscious healthcare markets. CLICK TO BUY ONLINE NOW! | Read full details

Practical biomaterials using industrial polymers for implants Published by Euromed Communications Our Price: £20.00 Reprinted from the Medical Devices Manual, Tim Ashton explains how a practical definition of a Biomaterial might be 'a material which is safe, has the necessary durability and can gain regulatory approval'. CLICK TO BUY ONLINE NOW! | Read full details

Preparing Health Technology Submissions for Pharmaceutical Products: Meeting Formulary Submission Requirements for New Product Assessments and Disease Area & Therapeutic Class Reviews Published by Urch Publishing Our Price: £1550.00 An Urch Pharmaceutical Industry Report, written by Dr Paul Langley, This report considers, in particular, the implications of the standards required in the NICE and WPM guidelines for manufacturers preparing reimbursement submissions. CLICK TO BUY ONLINE NOW! | Read full details

Presages to the coming war over generic biologics Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Kurt Karst and first published in Journal of Generic Medicines, Volume 1, Number 2, January 2004 CLICK TO BUY ONLINE NOW! | Read full details

Regulatory requirements Published by Euromed Communications Our Price: £25.00 Cynthia Sinclair of Medical Device Consultants, Inc. provides a broad overview of the key FDA regulatory requirements that all manufacturers or suppliers must take into account if they want to import and market medical devices in the United States. CLICK TO BUY ONLINE NOW! | Read full details

Scientific issues for biogenerics/biosimilars Published by Palgrave Macmillan Publishing Our Price: £16.00 This expert article was written by Robert I Roth and Nicholas M Fleischer and first published in Journal of Generic Medicines, Volume 2, Number 2, January 2005 CLICK TO BUY ONLINE NOW! | Read full details

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