25thmayconference Brochure

8/22/2019 25thmayconference Brochure

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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.


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APOLLO GLENEAGLES HOSPITAL

Located at 58, Canal Circular Road, Kolkata-54, Apollo Gleneagles Hospital is a 510-

bedded multispecialty tertiary care hospital. Patients describes the experience with the

Hospital as a perfect blend of technological excellence, complete infrastructure, competent

care and heartfelt hospitality

A joint venture of Apollo Group of Hospitals, India and Parkway Health of Singapore,

Apollo Gleneagles Hospital has emerged as one of the most promising healthcare

service provider in Eastern India. The Associated partner Parkway Group is a leading

healthcare group in Asia. It provides more than 70% of private healthcare in Singapore. Its

subsidiaries include Parkway Group Healthcare, which owns a network of regional

hospitals and medical centers in Malaysia, India and Brunei and Parkway Hospitals

Singapore, which owns three hospitals in Singapore - East Shore, Gleneagles, MountElizabeth Hospitals and Parkway Health Day surgery Centre.

This thriving hospital houses 7 Center of Excellence (COE) namely Heart Institute,

CancerInstitute,Neurosciences,Orthopedics,Gastroenterology,Transplant and Emergency.


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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)", to carry out research,

educational and training programs in quest of quality health care.

AHERF aims to undertake and promote scientific and medical research programs that

have a bearing on the health, social, economic and industrial needs of India.AHERF

leverages the strength of Apollo Group of Hospital which lies in its competent cliniciansand clinical researchers, a large number and variety of patients, state of art diagnostic and

therapeutic technologies and an excellent medical records system.

Research of the highest quality can only be carried out by trained investigators. The

Institutions vision is also to create educational programs in basic and specialized areas, in

areas where qualified human resources are much needed.

Clinical trials

AHERF is Indias single largest site solutions organization having experience ofcoordinating conduct of over650 clinical trials across several therapeutic areas over the

last decade. AHERF comprises ofalmost 80 Clinical Research Coordinators, almost

200 Principal Investigators on its panel across 11 sites. AHERF conducts trials in

phase 2, 3 and 4 wherein over 80% of clinical trials coordinated are international

multi-centric trials.

AHERF has established a benchmark in terms of ethics compliance and standards

across its sites. For multi-centric trials, AHERF has established a central ethics

committee which is registered with the Office of Human Resource Protection

(OHRP), US Department of Health whilst its institutional ethics committees at Chennai

and Hyderabad are also OHRP registered. AHERF also has built an in-house capability in

ethics and quality assurance for clinical trials across multiple sites.

Currently, 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.


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The Kolkata site over a span of seven years has been able to achieve excellence in

clinical research.

Clinical trials-Kolkata.

The clinical trials and research department, Apollo Gleneagles Hospital Limited(AGHL),

Kolkata was started in the year 2005. Ever since more than 100 clinical trials has been

conducted at the site.

The ethical aspects of the trials are collectively supervised and analyzed by the

Institutional Ethics committee (IEC). Composed of some of the most esteemed and

illustrious personalities of the society, the IEC have become a sign of pride for our

Clinical Research Activities.

At AGHL, Kolkata the clinical trials are very efficiently and smoothly carried out on the

Hospital premises. Owing to the availability of most premium level of infrastructuralsupport along with Investigators of the most qualified levels, several renounced clinical

research and trials outfits of the likes of Elli Lily, Novartis, Novo-nordisk, Sanofi have

chosen Apollo Gleneagles Hospital.


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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.

Therapeutic areas covered are Oncology (Medical and Radiation), Diabetics,

Gastroenterology, cardiology, Neurology Medicine and Critical Care.

Support staff:

Clinical research Co-ordinators:

The clinical trial department takes pride in its team of clinical research associates,

coordinators. Coming from diverse educational background such as Social sciences,

Hospital management, Clinical and Biotechnological background, the teams only anthem

is patient safety and well being.

They work in close collaboration with the Principle Investigator and have gathered

expertise in all clinical trials activities.

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. They conduct all activities according to

Cardiology

21%

Diabetology

19%

Gastroenterology

19%

Oncology(medica

l and Radiation)

18%

O and G

6%

Neurology

9%

Critical Care

8%

Clinical trials

-Therapeutic

area, 2006-

2013.

Kolkata.


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the applicable Institutional Standard operating protocols and work processes. The team

promotes guidelines compliance.

Pharmacy:A very well equipped pharmacy department takes care of all drug storage and drug

associated clinical research regulations. At AGHL, Clinical and Research pharmacist are

key fundamental members of the Clinical research study team. Their extensive skill in drug

dealing becomes immensely important while dealing with pharmacological aspect of a trial

like drug composition, dosage, contraindications, adverse effect and interactions of

ID(Investigational drugs). Along with the research coordinator, 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. The first batch saw involvement of ten postgraduate students from

different allied Life Sciences field join the training. Faculties from highly esteemed

education institutions like Indian Statistical Institute; Kolkata, National Institute of

Epidemiology, Chennai trained and oriented the trainee towards the vast field of clinical

research.

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.

With the successful completion of the first batch, AHERF Kolkata is now training the

second batch of intern. 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.

LLaammpp lliigghhttiinngg aatt AAHHEERRFF,, KKoollkkaattaa CCoonnvvooccaattiioonn,, 77tthhJJuullyy 22001122..


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On 7th July 2012, AGHL along with Eli Lilly

organized a Workshop on CCuurrrreenntt

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RReesseeaarrcchh ... 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. The

main objectives of deliberations were,

A). ICF and protocols should be very

effective scrutinized and reviewed by IEC

before granting approval. There was

extensive discussion and both Ethics

committee member and Investigatoractively participated in the discussion.

B) Conflict of Interest and how we can handle them.

C)Assessment of SAE causality and compensation- So even before the DCGI, CDSCO

amendments were incorporated, We at AHCL had debated incessantly on compensation.

D) The path ahead- While closing the workshop, the entire forum agreed that there is a lot

to do in clinical research and we need to stick to guidelines and strive to achieveexcellence in it.

This endeavor was very successful and plan was immediately in place to keep hosting

such workshops once in a year.

On 19TH October 2012, we had the second GCP training BBAASSIICC GGOOOODD CCLLIINNIICCAALL

PPRRAACCTTIICCEE PPRROOGGRRAAMM in a row, this time it was organized in collaboration with

Sanofi India.We had Senior Director, Clinical Quality and Research from Sanofi

addressing sessions on overview of the Clinical research Industry , Importance of Good

Clinical Practice, Informed consents and Safety reporting. Her session wascomplemented with input from our Clinical research and Quality Head, who threw some

light on the flips and flops of the research industry.

CCuurrrreenntt PPeerrssppeeccttiivvee

aanndd GGuuiiddaannccee oonn

CClliinniiccaall RReesseeaarrcchh ...


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25thmayconference Brochure