One Day Seminar on Challenges in Decentralized Procedure (DCP) Filings in Europe.

Pharmaceutical companies intending to market products in the EU must follow one of three distinct processes in order to obtain the required marketing authorizations - Centralized Procedure, Decentralized Procedure or Mutual Recognition Procedure. Of these, the DCP route, adopted to seek approvals where none currently exists, can be a challenging and complex process.

The AIPS Seminar is designed to assist in DCP Deficiency handling vis-a-vis multiple European Authorities. After providing an overview of the European Filing procedures, the seminar will focus on DCP Filing deficiencies,and study issues relating to their impact on the DCP review, the current trend of deficiencies, ways to address these deficiencies, the turn around time for addressing deficiencies etc.

The seminar is recommended for professionals in Process Teams, Analytical Teams, Purchase (API as well as KSM - Alternate sourcing and their impact on API resulting in variations at the formulators end vis-a-vis latest variation guidance which impacts cost of filing variations and launch dates], RA, Marketing, Quality and Production Planning Teams. Project Management officials, etc.

Venue: AIPS, Mumbai
Date: Saturday, May 8, 2010
For more details : info@aips.ac.inMay 2010

5 Day Workshop on Patent Fundamentals and Practice.

This training programme, designed for executives whose scope of work calls for a broad working knowledge of patents, will provide an insight into the related legal & practical issues. Eminent faculty will take the participants through sessions on Patent Basics, Prior Art Search, Data Mining, Search Strategies, Specification Drafting, Filing and Prosecution of Patent Applications including PCT applications, Opposition Procedures at the Indian Patent Office, Claim Interpretation and Analysis, Freedom to Operate guidelines, the Trade Secrets vis-a-vis Patents debate, etc.

Venue: AIPS, Mumbai
Date: May 14 - May 18, 2010
For more details : info@aips.ac.in

GVK Biosciences opens new new clinical pharmacology unit (CPU) in Ahmedabad

GVK Biosciences, Asia’s leading contract research organization has opened its new clinical pharmacology unit (CPU) in Ahmedabad, India. The Ahmedabad CPU has 3 wards and 110 beds and will conduct studies in healthy volunteers.

With this unit, GVK BIO’s capacity increases upto 254 beds. (144 at Hyderabad and 110 at Ahmedabad). The Hyderabad unit has undergone international audits, inspections and has accreditations from the USFDA, DCG(I), ANVISA (Brazil), AFSSAPS (France), WHO and the Ministry of Health, Turkey.

MCI president Dr Ketan Desai arrested by CBI on corruption charges

The Central Bureau of Investigation (CBI) has arrested Medical Council of India (MCI) president Dr Ketan Desai and two others for allegedly accepting a bribe of Rs 2 crore to grant recognition to a medical college in Punjab.

According to reports, Ketan Desai was arrested late last night following a CBI raid at his offices and residence in Delhi, Punjab and Ahmedabad. His associates Jitender Pal Singh and Dr Kanwaljit Singh were also arrested Dr Kanwaljit Singh is from Gyan Sagar Medical College in Punjab. Kanwaljit Singh was said to be caught with Rs 2 crore cash, which he was supposed to deliver to Dr Desai.

Openings for the position of Assistant Professors at NIPER

Openings for the position of Assistant Professors at NIPER (ROLLING/OPEN ADVERTISEMENT)

Pay band PB-3 Rs. 15600-39100 Academic Grade Pay of Rs. 8000/-. The initial pay in pay band is Rs. 30,000 plus AGP of Rs. 8000/-

The National Institute of Pharmaceutical Education & Research (NIPER) is an Institute of National importance established by an Act of Parliament under the aegis of Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India. The Institute is situated at S.A.S. Nagar(Mohali), Punjab adjoining Chandigarh the City Beautiful. The main thrust areas of research is Tuberculosis, Malaria, Leishmaniasis and Diabetes.

The Institute has excellent facilities for advanced education and research in pharmaceutical sciences and technology and is looking for faculty of high calibre and potential, willing to face the challenge of building this Institute into a center of excellence. The focus is on master’s, doctoral and postdoctoral programmes.

ESSENTIAL QUALIFICATIONS, EXPERIENCE & AGE

Assistant Professor: Ph. D with 1st class or equivalent grade at the preceding degree in the appropriate branch with a very good academic record throughout and at least five years of teaching/research/industrial experience with published work of high quality. Age Limit is 45 years.

Applications from prospective candidates are accepted throughout the year. Based on the qualifications and need of the department concerned, the applications shall be processed at regular intervals.

M.Pharm in The Tamil Nadu DR.M.G.R. Medical University

Applications called for entrance examination for Admission To M.Pharm in Government and Self-financing colleges under THE TAMIL NADU DR.M.G.R. MEDICAL UNIVERSITY

Completed Application Forms should be submitted on or before 29-04-2010 by 5.00 p.m.

Entrance Exam: 09.05.2010 (Sunday) 10.00 A.M. to 11.30 A.M.

Place: Chennai

The Entrance Examination will be of the undergraduate level covering all subjects and will contain 125 objective type questions each with four responses (A B C D) (English medium).

Each question will carry 1 (one) Mark. No negative marking

The Merit List will be drawn by computing the Entrance Examination Marks and the marks for experience, which will be for a total maximum of 100 marks (90 marks for entrance examination + 10 marks for experience including marks for hilly areas).

Tuition Fees
Government Colleges (Rs. per annum): 5,000
Self-financing Colleges (Rs. per annum): 45,000 (For 2009 – 2010)

Special fees and other fees are to be paid at the time of admission in respective colleges.

click here to download application form and prospectus.

Clinical Research Feud - a little Funny

Found the following questions in a survey conducted for a presentation titled "Clinical Research Feud" to be presented at the ACRP 2010 Global Conference in Tampa,FL


1. If an animal was to represent the role of study coordinator, which animal would it be?

2. If an animal was to represent the role of auditor, which animal would it be?

3. After an audit, where is the best vacation spot?

4. If an animal was to represent the role of Principal Investigator, which animal would it be?

5. If an animal was to represent the role of CRA, which animal would it be?

Chennai police to inquire into the role of drug inspectors in the expired drugs issue

Drug inspectors in Tamilnadu will be investigated on the expired drugs issue, said the Chennai city police commissioner.

Hmm, it is quite obvious that such a large scale illicit business may not have happened without the knowledge of the regulatory authorities. Having said that, not all Drug Inspectors are corrupt but there are cases, I have seen myself.

A retail pharmacy shop owner friend of mine was one day looking at some accounts when I visited him. I was not sure what he was doing and when I asked him he said, "I am looking at the sum collected from the Pharmacy shops in this area". Initially I thought it was some kinda association fund but the reason he told me as a little shocking. He was collecting the money to be given to the Drug Inspector. In local terms - "mamool"!

Shame!

Health minister of TN instructs Drug Control Dept to continue action against illicit drug traders

When Chennai and other parts of Tamil Nadu are flooded with expired drugs and illicit drug traders, the state health minister MRK Panneer Selvam reviewed the situation arising out of the recent raids and seizures of huge quantity of expired drugs by police and drug control officials from several parts of the state.In the review meeting called by the health minister in his office, besides the principal health secretary, it was attended by the director of Drugs Control Administration and other senior officers of the department.

According to sources, the minister was busy with the Pennagaram by-election, hence he could not comment so much on the present illicit drug trade in the state. Sources said the Minister has given strict instructions to the health department officials, especially to the drugs control director, M Bhaskaran to act properly and take immediate action on the illicit traders.