Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Regulatory Affairs: Open Access

GCP Responsibilities of an Investigator during Audit Inspection

Compliance with Good Clinical Practice and ICH guidelines will ensure subject safety, quality data, and speed up the review process. When the Personal Investigator signs Study Protocol for any Global study or, in the US, the FDA form 1572 (for IND studies), Read more…

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Posted by Peter Arnold - 22/02/2013 at 00:36

Categories: Medical, Pharmaceutical Regulatory Affairs: Open Access, Pharmaceutical Sciences   Tags: ,

Drug Abuse

Drugs are defined as the chemical substance which controls various diseases of human mankind and alters the behavior of the man. Drug abuse refers to the addiction to some of the substances which are harmful to health and restricted by the concerned authority. Read more…

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Posted by vanits - 01/02/2013 at 05:12

Categories: Medical, Pharmaceutical Regulatory Affairs: Open Access, Pharmaceutical Sciences   Tags: , ,

Online Pharmacies: An Approach to Counterfeit Drugs

In today’s world, drug is the major necessity of livelihood.  Today the people are busy in their life; they didn’t have time to take care of their health. This result in increase of diseases day by day parallel number of drugs is increasing. Read more…

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Posted by Samantha Adams - 18/01/2013 at 04:21

Categories: Medical, Pharmaceutical Regulatory Affairs: Open Access, Pharmaceutical Sciences   Tags: , ,

GMP for Clinical Trial Supply in India

There are many opportunities in conducting clinical trial in India but along with those opportunities comes challenges. Nine (9) of the fifteen (15) global bio-Pharma companies already maintain their own clinical research facilities in India. Read more…

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Posted by Peter Arnold - 16/01/2013 at 06:08

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New Therapy for Dentistry Faces

In the USA general dentistry faces strong competition from Implant Centers and corporate dental offices that offer integrated Cone Beams, oral surgeons, implant specialists, prosthedontists and in-house labs for complete treatment and restorations. Read more…

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Posted by vanits - 10/01/2013 at 23:19

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Auditing Tips and Techniques for Regulators, Sponsors/CROs and Investigators

Regulatory agencies, such as FDA and EMA, have requirements for tracking and early reporting of investigators non-compliance and serious breaches. Often non-compliance issues are allowed to continue through a trial or may not be detected until Read more…

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Posted by Peter Arnold - 07/01/2013 at 06:56

Categories: Medical, Pharmaceutical Regulatory Affairs: Open Access, Pharmaceutical Sciences   Tags: ,

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