CRO.pptx

Establishing pharmacovigilance programme

1. Contract research organization Miss. Gayatri K. Bahatkar Assistant Professor P. R. Patil Institute of Pharmacy, Talegaon sp

2. Definition A person / organization contracted by sponsor to perform one or more of sponsors trial related duties and functions. CRO- are service organization that provide services to wide variety of business like pharmaceutical industries, biotechnology industry , medical devices industry, govt institution , foundation , university. A Contract Research Organization (CRO) is a service organization which provides support to the pharmaceutical industry. It offers various pharmaceutical research that is essential for conducting clinical trials in the present boom, when various complications are involved in the drug discovery process.

3. Various companies are involved in his type of development many examples are the like Lupin , Quintil , Cipla, Zydus, Cadeila . They are also conduct these type of trails with the collaboration of many multinational companies and these Indian companies are making space in foreign. Need To save funds To save time Specialized services by specialized professionals

4. History Oldest CRO- food and drug research laboratories (1980) new jerrcy - closed in 1980 1975 and onward- there are many CRO generated and some are bioassay system, tegaris ,bushy run, HTI and Charles river laboratories that further slowly so many CRO emerged and due to economic pressure they are some kind of activity those activity known as merger as well as closer.

5. Services provided Biology- in vitro , in vivo, toxicology, lead identification, lead optimization, efficacy modeling, PK and PD. Chemistry – scale up synthesis ,API manufacturing, radio synthesis, analytical, bioanalytical method development , validation . Clinical services- phase 0, phase 1 to 3, site management, biostatics, report writing, PV. Pharmaceutics- formulation development, drug product manufacturing Drug regulatory- IND filing, NDA filing, Pre market approval CTD, Drug master file, Annual update .

6. How to select CRO for out sourcing Dependability Prior experience with activity / specific study Training of person Status/ type of equipment required to perform study Cost of the project State of facility Regulatory history of the organization State of IT system Financial soundness

7. Physical location and accessibility References and reputation Procedure in place to protect client confidentially Acceptability of study scheduling Format and details of study protocol Company position authorship The on time report delivery Openness to inspection by the spencer's Term of masters services agreement .

8. Role of contract research organization It provide support to the pharmaceutical biotechnology and medical device industries in the form of research services out sourced by contract basis. It is increases interdisciplinary collaboration and enhanced uses of advanced technology CRO is responsible for planning set up and day to day execution and management of its contracted clinical trial Handling and supervising the technical side

9. Main responsibilities that are completed by a CRO. 1. Implementation of systems and procedures for the conduct of clinical trials and assessment of the safety in carrying out those trials. 2. Taking complete responsibility to ensure that the CTS are conducted in accordance with the guidelines and regulations, whether they are specified by the pharmaceutical industry or by the companies they are carrying out the research for. 3. Following the terms of the research contract it has signed with the sponsor. 4. Communicating concerns associated with the trials to the sponsors on a regular and timely basis. These concems include the progress in the trial, complications, risks and more 5. Assuring to maintain quality and metrics throughout the procedure in order to get the accurate and unbiased results. 6. Last but not least responsibility of a CRO is to record the trial results and maintain accuracy in all those records.

10. Establishing national PV programmed In India ADR monitoring system started in 1986 with 12 regional center. 1997 India become member of WHO programmed for IDM managed bye UMC. Initially we have 6 regional center- new Delhi, Mumbai, Kolkata, Lucknow , Chandigarh, Pondicherry. 2004- india launched NPVPI -0.1 million world bank gant - ended in2005 2010- health ministry launched – PvPI –AIIMS (NCC)- IPC (NCC) (Dr, G.N.Sing )

11. Under PvPI – ADR monitoring started @ AMC- across medical college (MCI approved) AMC become responsible – collect ADR as per SOP and talking follow up – upload to vigiflow Individual case safety report ( ICSRs) are collected in predesigned ADR report form – 4 section Patient info Suspected adverse drug reaction Suspected medicine Reporter information

12. This ICSR reports to the NCC for quality and signal review – WHO UMC causality assessment system. 2006-2008- ICSRs 11633 ICSR reported :2009-2014- 78672 ICSR reported- so reporting increases Besides ADR reporting, PvPI develop medicine side effect reporting form in regional language of India However the present database of ADR on PvPI is not sufficient to represent the population which consume drugs Encouragement requires- physician , pharmacist nursing and paramedical staff, patient, pharmaceutical Company. Communication must needed- P-P-P-P Financial incentive for medical and non medical staff

13. Lack of time and overload Ignorance’s Required training programme , advertising Reporting of serious ADR Appointment of PV officer at every govt and private hospitals India contribution in Vigibase database was 2% till 2013

14. CDSCO Stakeholders UMC Sweden National health program Pharmaceutical company Professional bodies And forwarded to NCC – IPC Gaziabad Signal review panel Core training panel Quality review panel As well as the Strategic advisory committee Steering committee take a decision CDSCO zonal and subzonal office North, south, east, west zones AMC Report informed