Veeda was selected for the industrial training of Drug inspectors by CDSCO
 
Ahmedabad,8 May 2017. The Central Drug Standards Control Organization (CDSCO) needs to keep itself abreast of the fast-changing scientific innovations, evolving international regulatory framework and other developments. The central role of the Indian Pharma industry and the globalization necessitate, that the regulatory framework has to constantly evolve by integrating new developments. It is, therefore imperative for the present and future drug control officials to continuously upgrade their skills and knowledge, and gain expertise in the variety of subjects to measure up to such functional requirements.Therefore, the need to train the regulatory officers arises so that they can devise strategies for optimum utilization of available resources rises and CDSCO planned to impart specialized training to the Drugs Inspectors for uniform implementation of GMP and GCP inspections for supplying quality drugs globally.
VEEDA Clinical Research was selected to train the Drug inspectors. The objective of the training was to train officers in regulations of pharmaceuticals with the real time exposure to the pharmaceutical operations or controls. 54 Drug inspectors in two groups have attended the training session at Veeda Clinical Research Facility in Ahmedabad. Areas such as Technical ,Legal ,Quality audits and inspections - Planning, Procedures, Report writing ,Quality Standards of Drugs, Medical Devices ,International regulatory framework ,Investigation techniques ,were focused in this training sessions. The participation from the delegates was really enthusiastic and interactive. A brief overview of BA/BE and Corporate presentation was given by Dr. Venu Madhav, COO at VEEDA CR. The delegates were apprised with brief presentation about different departments and their workflow (Biopharmaceutics and Project Management, Clinical Research and Bioanalytical Research) by HODs and senior persons of respective departments. Additionally, they were given exposure on Pharmacokinetics and Statisitcal aspects as well as Quality assurance aspects in BA/BE studies. Later queries from the delegates were answered and the required knowledge about the systems and processes was also provided. They were also taken to round of whole facility so that they can see the clinics, laboratories, equipments and workflow as well as interact with the working scientists.
This training will help impart fundamental skills and knowledge in aspects of Clinical Research and BA/BE studies in India and also acquaint the officials with international regulatory practices so the national regulations can become more efficient. Ultimately, it will help officials and CDSCO to achieve their objective of safeguarding public health in India by ensuring availability of safe, effective and quality medicines. As countries globally are concerned about safety and efficacy of medicines to be supplied for the sake of patient safety,such kind of training will really help the Drug inspector to know the real problems and sources of errors.
About Veeda CR
Veeda CR is a Contract Research Organization committed to serve its customers with the Best-in-Class Scientific Expertise and Demonstrated Regulatory Compliance. Veeda CR is a trusted partner of choice for conduct of healthy Volunteer BA/BE studies, Patient based PK End-point and PD-End point studies.
 
Veeda Advantage
  • 100% data review by Bio-analytical Quality Monitors
  • State of art Bio analytical Lab equipped with highend sensitive equipment’s to achieve the required LLOQ.
  • Trained Bio analysts to handle complex sample processing
  • Proven regulatory track record with 11 USFDA, 5 European, 4 WHO & 5 ANVISA audits
  • Bio-analytical Unit with more than 590 validated assays in its library of compounds including 36 NCE methods, 20 more under development.
VEEDA CLINICAL RESEARCH PVT. LTD.

Vedant Complex, Beside YMCA club S.G.Highway, Vejalpur,Ahmedabad-380051,Gujarat India

Phone:  +91 79 3001 3000 | Fax:  +91 79 3001 3010 | Email:  info@veedacr.com

Website:  www.veedacr.com