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Welcome to GCP HelpDesk Website
In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations. This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Reasearch with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email. Feedback Due to the nature of the clinical research industry and we understand that there is always scope to learn more and improve and we request you to provide your feedback on the design, suggested features or problems and errors you might discover to our team at Feedback page and we appreciate your suggestion and comments. |
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Clinical Research Today
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 On April 30, 2013, the U.S. Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age ...
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 From 29 April 2013, the TGA is changing its terminology - the word 'inspection' is replacing the word 'audit'.
TGA inspectors regularly conduct inspections of manufacturers using a risk-based approach. These inspectors were formerly known as auditors ... READ MORE
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On April 29, 2013, the U.S. Food and Drug Administration approved Kcentra rothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in ... READ MORE
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On April 8, 2013, the U.S. Food and Drug Administration approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of ... READ MORE
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On March 29, 2013, The U.S. Food and Drug Administration approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Type 2 diabetes is the most common form of the disease, affecting about ... READ MORE
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On March 13, 2013, the U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove ... READ MORE
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 OTTAWA - On February 24, 2013, the Honourable Leona Aglukkaq, Minister of Health and MP James Bezan (Selkirk-Interlake, MB), announced that Health Canada intends to strengthen its health warnings about the dangers of tanning beds.
"The Harper Government is committed to protecting ... READ MORE
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On Feb. 25, 2013, the U.S. Food and Drug Administration expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. READ MORE
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On Feb. 22, 2013, the U.S. Food and Drug Administration approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. HER2 is a protein involved in normal cell growth. It is found in increased amounts on some ... READ MORE
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 The European Medicines Agency has opened a public consultation on two standard paediatric investigation plans (PIPs) for two specific types of cancer with unmet medical needs in children, acute myeloid leukaemia and rhabdomyosarcoma.
A PIP sets out ... READ MORE
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The newly revised Good Supply Practice for Pharmaceutical Products (GSP) was recently adopted at the executive meeting of the Ministry of Heath and officially issued. It will go into effect as of June 1, 2013. The revision of ... READ MORE
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