International Conference on Clinical Trials

Clinical research is an indispensable phase in drug development process to evaluate the efficiency and safety of drug. The process is highly specialized and involves huge investments to introduce new drug capable of curing the ailments.Indian CRO industry is competitive enough to conduct trials to meet the global standards. It is felt that there should be robustness in the IRB and regulatory mechanism so that the clinical trial data generated in India is well accepted globally.

Objectives:

•To create a platform for deliberation on creating conducive regulatory for clinical research to meet global standards.

•To showcase the competitiveness of Indian Clinical Research industry to the International stakeholders and also to facilitate meaningful interactions for possible joint ventures. Key learnings

•Learning of grounding economic and operational realities in conducting international trials. •Creation of working environment that is flexible enough to deal with the regulatory requirements.

•Best practices in global recruitment strategy and how best they can be applied in different regions.

Start Date: Nov 19, 2010, End Date: Nov 20, 2010
Venue: Intercontinental The Lalit Mumbai, Magestic Hall, Sahar Airport Road, Andheri (East), Mumbai Maharashtra India

Contacts :
Ravikiran Veligeti [Executive Officer ]
Confederation of Indian Industry
CII Knowledge & Innovation Initiatives
3rd Floor, IGSSS Building
28, Instutional Area
Lodi Road
New Delhi-110003
Delhi India
Phone : 91-11-45772019
Fax :91-11-45772014
Email : ravikiran.v@cii.in

M.Pharm at BITS Pilani

BITS Pilani invites applications for Higher Degree Programmes for the Second Semester 2010-11 starting in January 2011

Programmes Offered at BITS, Pilani - Pilani Campus

M. Pharm.

M. Pharm.(with specialization in Pharmaceutical Chemistry/Pharmaceutics)

More journals

Three more journals which publish negative results:
http://www.jnrbm.com/
http://www.jnr-eeb.org/index.php/jnr
http://www.arjournals.com/ojs/?journal=Biol&page=about&op=editorialPolicies#focusAndScope

Journal that publishes NEGATIVE RESULTS

Here is a journal which publishes NEGATIVE RESULTS in clinical trial that we don't find commonly in our journals. Hope it will benefit many people.

http://www.pnrjournal.com/

It's free and those who have Medknow id don't even require to register again.

Suspension of licence to Manufacture/Sale/Distribution of Rosiglitazone

Drugs Controller General of India has requested All State Drug Controllers to suspend the Manufacture/Sale/Distribution of Rosiglitazone and rosiglitazone FDCs following the recommendation from an expert committee that was constituted to examine the safety issue of Rosiglitazone.

European Medicine Agency (EMEA) and U.S. FDA recently suspended the marketing authorisation of rosiglitazone and rosiglitazone FDCs due to the cardiovascular events and adverse effects on lipid profile.

GUIDANCE ON CLINICAL TRIAL INSPECTION

Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare has released the guidance document on Clinical Trial Inspections

The purpose of this programme is to provide direction to inspectors/CDSCO officers for conducting inspection of site of clinical trial, sponsor / CRO’s facilities involved in clinical trial and information to investigators, sponsor/ CRO’S about procedures for inspection and follow up
of action.

This Clinical trial inspection programme will cover all clinical trial sites and sponsor /
CRO’s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act.

CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the Clinical trial, name, address, contact number of clinical trial site, sponsor /
CRO’s facilities to be inspected. It may also identify the type and purpose of the inspection and provide background materials like study protocol, CRF etc.

Inspection can be carried out as a routine surveillance or for any specific cause(s).Study may be selected for inspection based on, but not restricted to the following criteria:

1. Nature of study
2. For regulatory decision based on clinical trial data
3. Data irregularities
4. Complaints
5. Vulnerability of subjects
6. Number of CT including number of subject enrolled at a particular site

Drugs and Cosmetics (Amendment) Act 2008

The Drugs and Cosmetics (Amendment) Act 2008 was published on 5th December 2008.

Click here to download a copy of the same.

Good Distribution Practices(GDP).

Drugs Controller General of India (DCGI) will be setting up a committee to oversee the formulation of guidelines for the Good Distribution Practices(GDP). The decision was taken at a recently held meeting state drugs controllers.

Karnataka Drugs Controller Dr BR Jagashetty was mandating the need for a dedicated guideline for good distribution practices. Now the DCGI has consented for formulation of a specific guideline that would insist on recall, discard and destroy of date expired drugs, substandard and defective packaged products.

Short term courses at NIPER

In an effort to generate revenues with the help of private partners to run the newly established NIPERs, the Department of Pharmaceuticals (DoP) is planning to launch some short term courses in the new NIPERs as per the detailed project report submitted by the consultant firm, Deloitte Touche Tohmatsu Pvt Ltd. Courses like those on intellectual property rights concerning the pharma industry, short term courses for the employees of the pharma companies, course on emerging sectors like biopharma are being planned in these institutes.

Private partners for NIPERs

The Department of Pharmaceuticals (DoP) is mulling over different ideas to generate revenues with the help of private partners to make the new NIPERs fully functional and autonomous.

A proposal under consideration is to leave some revenue generating activities like running hostels, auditorium, guest house, recreation and sports, maintenances etc to the private partners.

A suggestion also has come for full or part running of the exclusive courses under the PPP in some NIPERs. Though the detailed project report had suggested four types of collaboration, the DoP is yet to make a final decision yet on these proposals.

The new NIPERs, set up at Hajipur in Bihar, Rae Bareli in Uttar Pradesh, Ahmedabad in Gujarat, Hyderabad in Andhra Pradesh, Kolkata in West Bengal and Guwahati in Assam, are currently run with the help of mentor institutes already existing in these places. The government had approved setting up of six more institutes under NIPER in 2007 initially for two years, which had since been extended up to 2011.