Conference Day One: 7 December 2010, Tuesday

Conference Day One: 7 December 2010, Tuesday »

Conference Day Two: 8 December 2010, Wednesday »

last modified: 08 November '10

8am

Registration and refreshment

9am

Organiser’s welcome remarks: Terrapinn Asia

9.05am

Chairman’s opening remarks

LEADERSHIP ROUNDTABLE-INNOVATIONS AND STRATEGIC PARTNERSHIPS

9.15am

India’s Visionary Leaders Panel: Propelling India’s growing pharmaceutical industry through innovations and strategic partnerships

The promises and challenges for India’s pharmaceutical players in an era of globalization
Developing India’s emerging innovations and analyzing its impact in the country’s pharmaceutical industry
Looking into the global business opportunities that will drive global expansion and growth for Indian pharmaceuticals
Finding the right business model and strategies for Indian pharmaceuticals to achieve success in the global pharmaceutical arena

10.15am

Morning refreshment

Outsourcing Opportunities and Partnership Models for Conducting Trials in India

11.15am

Chairman’s opening remarks

11.25am

Keynote: The role of India in fast tracking clinical developments for global pharmas and biotechs: current and future

Assessing the regulatory environment, infrastructure built up and talent availability in India to determine your clinical trial strategies
Strategizing stages and therapeutics area focus of your clinical trial activities in India for maximum efficiency and return: best practices and case studies
Assessing different partnership models in conducting trials in Asia

11.55am

Strategies and partnerships for global pharma, biotechs & CROs in India

Analysing existing clinical operation models in India: own office, project outsourcing or long term alliance?
Local CROs or international CROs: competitive advantages analysis
Monitoring and managing partnerships to ensure compliance and safeguard results
Accessing viable capital solutions through strategic partnerships, co-development possible?

12.15pm

Panel: Assessing the opportunities and challenges in conducting clinical trial in India

Assessing the key advantages for exploring India for clinical trial development
Discussing strategies and partnership opportunities in accessing India’s advantage
Key challenges to overcome: unethical trials, approval delay, clinical data sharing, and certified investigator shortage
Reviewing success and failure case studies

1pm

Networking luncheon

Regulation Considerations in Conducting Trials in India and other Asian countries

2.30pm

Regulatory review at the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organization (CDSCO): science, quality, and speed

Determining factor for expediting CTA approval time with DCGI
The CDSCO’s move to be more “science” based
What regulators and the industry should do to enhance the application review process
India’s Role in Global Drug Development —A Regulatory Agency’s Perspective

3pm

Understanding the regulatory considerations for conducting biosimilar clinical trials

Essential requirement for the clinical program to be part of a risk-based comparability assessment
EU current guidance and draft guidance on quality issues and non-clinical and clinical studies
Indication specific trials and it’s impact on timelines, cost and location of clinical trials

3.30pm

Networking break and exhibition visit

Strategies in Conducting Clinical Trials in Different Therapeutics Areas

4.30pm

Case study: Strategies in conducting successful interventional oncology trials in India

Quality patient pool, faster recruitment, what else does India offer?
Overcoming operational and logistical challenges in conducting oncology clinical trials in India
Developing successful partnerships with Pharmas, CROs, and sites in India for oncology trials

5pm

Case study: Role of pharmacists in the management of Oncology Clinical Trials

Pharmacists responsibility within clinical trials in general in Europe and India
The service which could and should be provided by the pharmacist
The advantage of participation of the oncology pharmacists in the clinical trials by a work flow plan

5.30pm

Case study: Conducting cardiology clinical trials in India—advantages, challenges, and best practices

India’s advantages in cardiovascular trials—patients, investigators and cost
Overcoming the practical and ethical challenges when conducting cardiovascular clinical trials in India
Best practices and growth prospects of cardiovascular clinical development in India

6pm

Chairperson’s closing remarks

6.10pm

End of conference day one

Conference Day One: 7 December 2010, Tuesday »

Conference Day Two: 8 December 2010, Wednesday »

last modified: 08 November '10

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Conference details

Conference:

Day 1

7th December 2010 8am - 5:30pm

Day 2

8th December 2010 8am - 5:30pm

Workshops:
Pre conference workshops
6th December 2010 9am-5pm

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