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WORKSHOP ON GOOD CLINICAL PRACTICE AND LATEST CHANGES IN INDIAN REGULATIONS (Schedule Y) Organised by APOLLO GLENEAGLES HOSPITAL,KOLKATA

, 58, Canal Circular Road,Kolkata-700054. Jointly with Novo Nordisk, India.

It provides more than 70% of private healthcare in Singapore. India and Parkway Health of Singapore.APOLLO GLENEAGLES HOSPITAL Located at 58. The Associated partner Parkway Group is a leading healthcare group in Asia. Kolkata-54. Mount Elizabeth Hospitals and Parkway Health Day surgery Centre.Transplant and Emergency. Canal Circular Road.East Shore.Gastroenterology.Neurosciences. India and Brunei and Parkway Hospitals Singapore. competent care and heartfelt hospitality A joint venture of Apollo Group of Hospitals.Orthopedics. which owns a network of regional hospitals and medical centers in Malaysia. This thriving hospital houses 7 Center of Excellence (COE) namely Heart Institute. complete infrastructure. Apollo Gleneagles Hospital has emerged as one of the most promising healthcare service provider in Eastern India. Patients describes the experience with the Hospital as a perfect blend of technological excellence. Gleneagles. Its subsidiaries include Parkway Group Healthcare. CancerInstitute. . which owns three hospitals in Singapore . Apollo Gleneagles Hospital is a 510bedded multispecialty tertiary care hospital.

AHERF is in the process of further consolidating new centers within the Apollo Hospitals wherein almost 11 new centers are likely to be part of AHERF sites for clinical trials in order to promote clinical research in a best-in-class trials management framework. AHERF has established a central ethics committee which is registered with the Office of Human Resource Protection (OHRP). AHERF conducts trials in phase 2. 3 and 4 wherein over 80% of clinical trials coordinated are international multi-centric trials. economic and industrial needs of India. state of art diagnostic and therapeutic technologies and an excellent medical records system. social. to carry out research. For multi-centric trials.AHERF leverages the strength of Apollo Group of Hospital which lies in its competent clinicians and clinical researchers. AHERF also has built an in-house capability in ethics and quality assurance for clinical trials across multiple sites. almost 200 Principal Investigators on its panel across 11 sites. . a large number and variety of patients. educational and training programs in quest of quality health care. in areas where qualified human resources are much needed. The Institution’s vision is also to create educational programs in basic and specialized areas. AHERF has established a benchmark in terms of ethics compliance and standards across its sites. Research of the highest quality can only be carried out by trained investigators. US Department of Health whilst its institutional ethics committees at Chennai and Hyderabad are also OHRP registered. AHERF comprises of almost 80 Clinical Research Coordinators. AHERF aims to undertake and promote scientific and medical research programs that have a bearing on the health.APOLLO HOSPITALS EDUCATIONAL AND RESEARCH FOUNDATION The Apollo Hospitals Educational and Research Foundation(AHERF) is an independent entity recognized by the Department of Scientific and Industrial Research (DSIR) as a "Scientific and Industrial Research Organization (SIRO)". Clinical trials AHERF is India’s single largest site solutions organization having experience of coordinating conduct of over 650 clinical trials across several therapeutic areas over the last decade. Currently.

the IEC have become a sign of pride for our Clinical Research Activities. Clinical trials-Kolkata.The Kolkata site over a span of seven years has been able to achieve excellence in clinical research. Composed of some of the most esteemed and illustrious personalities of the society. several renounced clinical research and trials outfits of the likes of Elli Lily. At AGHL. Ever since more than 100 clinical trials has been conducted at the site. Novartis. The clinical trials and research department. Sanofi have chosen Apollo Gleneagles Hospital. Kolkata was started in the year 2005. Apollo Gleneagles Hospital Limited(AGHL). Owing to the availability of most premium level of infrastructural support along with Investigators of the most qualified levels. The ethical aspects of the trials are collectively supervised and analyzed by the Institutional Ethics committee (IEC). . Novo-nordisk. Kolkata the clinical trials are very efficiently and smoothly carried out on the Hospital premises.

Kolkata. Critical Care 8% Neurology 9% Cardiology 21% O and G 6% Clinical trials -Therapeutic area. coordinators. 20062013. Diabetics. All of them attend regular protocol training sessions conducted by the concerned study monitor and respective Contract Research Organizations(CRO) along with frequent off the shore training workshop as and when required. Coming from diverse educational background such as Social sciences. the team’s only anthem is patient safety and well being. Oncology(medica l and Radiation) 18% Diabetology 19% Gastroenterology 19% Support staff: Clinical research Co-ordinators: The clinical trial department takes pride in its team of clinical research associates. Hospital management. cardiology.Investigators: There are about 20-35 consultants out of a full house of 110 highly trained and experienced consultants who actively participate and practice clinical trials/research. Neurology Medicine and Critical Care. Therapeutic areas covered are Oncology (Medical and Radiation). They work in close collaboration with the Principle Investigator and have gathered expertise in all clinical trials activities. Gastroenterology. Clinical and Biotechnological background. They conduct all activities according to .

adverse effect and interactions of ID(Investigational drugs). Clinical and Research pharmacist are key fundamental members of the Clinical research study team. At AGHL. With the successful completion of the first batch. contraindications. . Kolkata. The team promotes guidelines compliance. Chennai trained and oriented the trainee towards the vast field of clinical research. Along with the research coordinator. Comprehensive modules were designed which meet all the current trend of the field and groomed the trainees to embrace clinical research industry in the best of spirits. Faculties from highly esteemed education institutions like Indian Statistical Institute. 7 t h J u ly 2 0 1 2 . L a m p lig h t in g a t A H E R F . Their extensive skill in drug dealing becomes immensely important while dealing with pharmacological aspect of a trial like drug composition. Over the last two years AHERF Kolkata has been instrumental in emphasizing the importance of Ethics and Good clinical practice in clinical research through regular workshops and CMEs on Good Clinical Practices and Ethical Issues in Clinical research.the applicable Institutional Standard operating protocols and work processes. Pharmacy: A very well equipped pharmacy department takes care of all drug storage and drug associated clinical research regulations. research pharmacist also attends trainings from time to time. AHERF Clinical Research Certification course at Kolkata: Apollo Gleneagles Hospital being part of AHERF started clinical research certification course from July 2011. K o lk a t a C o n v o c a t io n . dosage. AHERF Kolkata is now training the second batch of intern. National Institute of Epidemiology. The first batch saw involvement of ten postgraduate students from different allied Life Sciences field join the training.

“Current Perspective and Guidance on Clinical Research” ”. B) Conflict of Interest and how we can handle them. D) The path ahead. . This endeavor was very successful and plan was immediately in place to keep hosting such workshops once in a year. A). Clinical Quality and Research from Sanofi addressing sessions on overview of the Clinical research Industry .. C) Assessment of SAE causality and compensation. Her session was complemented with input from our Clinical research and Quality Head.While closing the workshop. we had the second GCP training “BASIC GOOD CLINICAL PRACTICE PROGRAM” in a row. A team From Eli Lilly spearheaded by Senior Directors along with Clinical research department debated and deliberated on the flip and flops of Clinical Research and trial industry. who threw some light on the flips and flops of the research industry. We at AHCL had debated incessantly on compensation. this time it was organized in collaboration with Sanofi India. There was extensive discussion and both Ethics committee member and Investigator actively participated in the discussion. CDSCO amendments were incorporated. Importance of Good Clinical Practice.On 7th July 2012.. ICF and protocols should be very effective scrutinized and reviewed by IEC before granting approval. On 19TH October 2012. AGHL along with Eli Lilly organized a Workshop on “Current P e r s p e c t iv e a n d G u id a n c e o n C lin ic a l Research” ”.So even before the DCGI. Informed consents and Safety reporting. The main objectives of deliberations were.We had Senior Director. the entire forum agreed that there is a lot to do in clinical research and we need to stick to guidelines and strive to achieve excellence in it.