Workshop on Drug Master Files - Compilation & Compliance
May 22 and 23, 2009 .
Venue: AIPS, Goregaon (West), Mumbai
A Drug Master File (DMF) is a confidential, proprietary asset containing complete information on an API, and plays a crucial role when applying for regulatory approvals and Market Authorization. Acting as a master document, the DMF is important in maintaining current supplier agreements as well as in developing new business relationships and their preparation is, therefore, an important function in pharmaceutical organizations.
This workshop aims to train executives on how to prepare reliable and efficient DMFs that are compliant with official guidelines and requirements. An interactive teaching method will be used, and participants will gain an understanding of the role of the DMF in the regulatory approval process, how to compile a DMF in different jurisdictions including what to include/ not include, maintenance of the DMF, strategy to avoid unfavourable reviews, etc. Executives from the RA, R&D, Quality Assurance and Control, Manufacturing and Validation will find participation especially useful.
Workshop on TRADEMARKS, GEOGRAPHICAL INDICATIONS
Apart from the Fundamentals, sessions will cover areas such as Practice in India, Trademark Registration in India and internationally, opposition procedures, International Treaties, Role of Enforcement authorities, Trademark Search, Trademark Licensing and Management, Brand Valuation, GI fundamentals and protection, Geographical Indication Act 1999 etc.
Friday, May 8, 2009
No proper faculty in many Pharmacy colleges in India
A recent press article stated that the Pharmacy Council of India (PCI) will soon take strict action, including cancellation of admission process, against the pharmacy colleges which have been found flouting rules and regulations and are running without proper faculty.
It was noted that the PCI has found several pharmacy colleges violating rules to run their institutions through the surprise inspections on pharmacy colleges which the PCI had started last year to pin down the institutions that are running without proper faculty,.
Major observation during these surprise inspections is that many colleges do not have proper faculty and this issue has been referred to the PCI's legal department for vetting and once the legal department clears the files, the PCI will initiate strict action, including suspension of admission process, against such institutions.
Many Pharmacy colleges in the country set up a team of Faculty during the time of inspection and do not really have enough faculty as prescribed by the PCI. I have seen so many colleges call up their old students (the staffs call up their friends) and arrange the required staff on the day of college inspection
This kind of malpractices will definitely affect the quality of the Pharmacy education and it is time that the educational institutions realize their responsibility to provide quality education. One reason for this shortage of Faculty is low salary scale and by increasing the Pay scale of Pharmacy Faculties, these educational institutions can attract more people to take up Teaching profession.
Hope the stakeholders do something about this and help the Pharmacy Education standard in the country rise up.
It was noted that the PCI has found several pharmacy colleges violating rules to run their institutions through the surprise inspections on pharmacy colleges which the PCI had started last year to pin down the institutions that are running without proper faculty,.
Major observation during these surprise inspections is that many colleges do not have proper faculty and this issue has been referred to the PCI's legal department for vetting and once the legal department clears the files, the PCI will initiate strict action, including suspension of admission process, against such institutions.
Many Pharmacy colleges in the country set up a team of Faculty during the time of inspection and do not really have enough faculty as prescribed by the PCI. I have seen so many colleges call up their old students (the staffs call up their friends) and arrange the required staff on the day of college inspection
This kind of malpractices will definitely affect the quality of the Pharmacy education and it is time that the educational institutions realize their responsibility to provide quality education. One reason for this shortage of Faculty is low salary scale and by increasing the Pay scale of Pharmacy Faculties, these educational institutions can attract more people to take up Teaching profession.
Hope the stakeholders do something about this and help the Pharmacy Education standard in the country rise up.
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