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Harmonized clinical governance regulatory framework for Africa

17 February, 2012

By Solomon Sackitey

We need a harmonized clinical governance regulatory framework for Africa.

Why or why not? And whose responsibility should it be? Should African governments and private institutions fold their arms and rely on the major pharmaceutical companies in the industrialized world to develop and implement such frameworks for them? My opinion is a “big no, no”.

In pursuing such initiatives, local community leaders including women who are also conversant with the language and culture of their localities can be especially helpful.


STEVE JOBS’S DEATH WILL ACCELERATE e-CLINICAL RESEARCH
06 October, 2011

By iraup admin

FIRST OF ALL, I WOULD LIKE TO DEDICATE A FEW MOMENTS OF SILENCE IN MEMORY OF THE LATE APPLE COMPUTER’S CO-FOUNDER, STEVE JOBS (1955-2011).

In recent years, the impact of Information Technology on Clinical Trials and Telemedicine has been profound, to say the least. Smart phones are now gaining momentum in the recruitment of clinical trials volunteers.

Additionally, Smart phones have been used in tracking counterfeit drugs in the developing countries and for pharmacovigilance initiatives (monitoring of post-marketing safety of drugs).

Computer Technology has been dictating the pace for the Regulation of biopharmaceutical products in the global healthcare market.

Apple Computer, under the leadership of the late Steve Jobs, has been one of the major players in the e-Clinical and e-Healthcare World. How do you think his death will impact new drug trials worldwide, drug regulations around the world, pharmacovigilance and e-Healthcare in general?

As a cancer patient whose foresight has motivated medical researchers and information technology professionals, Steve’s death will not be the end of e-Health innovations but will spark a whole new enthusiasm not only in cancer research, but in drug and medical device development besides the recruitment of human subject volunteers even from the most remote areas of the world and beyond.


YOUR CHANCE TO CHANGE THE RULES: The Common Rule

by iraup admin

26th July, 2011

The United States Health And Human Services (HHS) has, on July 22, 2011, published for public comments, proposed changes to the rules for the protection of human subjects in medical research. This vision has long been overdue in view of the rapid technological, regulatory and scientific advancements taking place globally. More here….

What else do you believe needs to be added to the proposal or be clarified in the list provided? Enter the ID number HHS-OPHS-2011-0005 here to submit your comments to the HHS.




Overseas regulators toughen clinical trial stance. December 1, 2008 — 12:03pm ET By John Carroll; Firecebiotech.com.

The Wall Street Journal weighs in this morning with a feature looking at the increasingly tough stance overseas regulators are taking to the clinical trials being conducted around the world. India, for example, is probing the screening measures used in a vaccine trial after a baby in the study died. Polish investigators want to know why two seniors died while taking an experimental bird flu vaccine being developed by Novartis. For additional information, read..


eSubmission—EMEA Key dates and timelines .
- From 1 January 2009, the EMEA will strongly recommend electronic-only submissions, either in eCTD or non-eCTD format (eCTD is the recommended electronic format).
- From 1 July 2009, the EMEA will strongly recommend eCTD-format electronic-only submissions. For additional information, please go to key dates.

First ever patient administered an siRNA cancer treatment. By Nick Taylor; 05 Jun-2008. In-pharmatechnologist.com. A patient has completed the first successful dosing cycle with small interfering RNA (siRNA) for the treatment of cancer in a clinical trial. The patient was administered with four doses of Calando’s CALAA-01, a targeted siRNA nanoparticle, over a two week period. More ...

Unapproved Cough and Cold Products. 06 June 2008. The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Scientific Laboratories Inc. This action bars the firm from making and distributing drug products until its manufacturing operations comply with law and its products are FDA approved. Posted 28 May, 2008. More ...

 
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