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Leveraging
Clinical Development Opportunities in India
Dr. Nermeen Varawalla
Vice President, Investigator Relations
PRA International
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India
presents a compelling environment for global clinical trials because
of its access to investigators, large patient populations with
diseases of the industrialized and developing world, a cost-effective,
English-speaking graduate workforce, and progressive regulatory
environment. These benefits are now well recognized by the global
pharmaceutical industry. Moreover, because of India's pristine
FDA audits, continued streamlining of regulatory approvals and
demonstrated intent to uphold international intellectual property
standards, the country has become even more attractive as an important
locale for clinical development.
As a result, multinational pharmaceutical companies are striving
to build clinical development capabilities within their local
operating companies in India, and the country's nascent CRO industry
is enjoying an annual growth of about 40%. This, however, poses
resourcing constraints and unresolved ethical issues about the
robustness of patient consent. Hence, it is becoming increasingly
important for sponsors to select investigators, sites and resources
that will be able to deliver data of the quality and integrity
that they seek.
This
presentation will draw on recent experiences and case studies
related to the benefits and challenges of conducting clinical
trials as well as data management in India.
This
audio conference will cover:
- The benefits
of conducting clinical development in India
- Recognizing
the potential challenges
- Understanding
the dynamism of the current clinical development atmosphere
- How to
utilize the opportunities to best meet sponsor needs
About
the speaker:
Dr.
Nermeen Varawalla, Vice President of Investigator Relations, leads
the corporate development effort for India at PRA International-a
global CRO with 2,700 employees, covering 68 countries on six
continents. Nermeen has a strong interest in the utilization of
emerging world countries for global clinical trials and has established
PRA's capabilities in Mumbai and Pune, India.
Prior
to joining PRA, Nermeen was the founder of PerinClinical, a niche
India-focused CRO. Before that she worked with Accenture's Health
& Life Sciences Business Consulting Practice in London in the
area of drug development.
Nermeen
received her medical training at the KEM group of hospitals, Mumbai,
India. She was awarded the Rhodes Research Fellowship to the University
of Oxford where she conducted her doctoral research in Molecular
Genetics. Nermeen practiced as a specialist at two of the UK's
leading NHS Hospitals. She then obtained her MBA at INSEAD. Dr.
Varawalla is a recognized industry expert on clinical development
in India and is a frequent and respected speaker at international
conferences.
Who should
attend?
- Heads of
R&D
- VPs Clinical
Development
- Directors
of Clinical Operations
- Therapeutic
Area Heads
- Program
and Clinical Study Managers
- Directors
of Outsourcing and Procurement
- VPs Global
Data Management
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