Emerging markets have experienced rapid growth in all areas of clinical research, but despite this trend there remain gaps in understanding how to best run trials in these regions. Pharm-Olam invites you to explore issues concerning the potential of India, Latin America, South Africa, and Russia for your drug development.

Join us to learn about:

• Regulatory changes and the best strategies for faster approval
• Best practices for selecting sites and starting clinical trials quickly
• Reduced overall costs with higher enrollment and lower treatment costs
• Incidence of particular indications across many therapeutic areas
• How emerging markets differs from traditional markets of research

The volume of clinical trial activity in India in the last decade has boomed, but the capacity for additional research remains among the highest in the world. Learn about how pending changes to the regulatory process may affect international studies and ideal therapeutic areas for research.

With the highest population growth rate in the world (11.4%) and over 60 million people in its four largest metro areas. The region’s population and economy continue to boom, driving strong growth in pharmaceutical sales and research across all therapeutic areas.

South Africa continues to grow as the best nation to conduct clinical research in Africa. Learn about how South Africa’s diverse population and mix of public and private research hospitals make the country a strategic location for clinical trials across many therapeutic areas. The discussion will also include a review of South African regulatory, FDA inspections, and the growing need for clinical research.

Russia and the neighboring states of Ukraine, Belarus, and Georgia are one of the fastest growing clinical research areas in the world. With major population centers and large medical institutions, patient access and motivation to participate are excellent. The centralized healthcare system in the region allows for established databases of patients with diagnosed medical needs — leading to faster study completion.

The capital cities of Russia (Moscow), Ukraine (Kiev), Belarus (Minsk), and Georgia (Tbilisi) have a combined metro population of over 18 million people.

The complimentary seminar is only available to employees of pharmaceutical, biotech, device, and medical venture capital companies. Seating is limited, so reserve your space by emailing

nj@pharm-olam.com

Please include attendee names and contact information

The complimentary seminar is only available to employees of pharmaceutical, biotech, device, and medical venture capital companies. Seating is limited, so reserve your space by emailing

nj@pharm-olam.com

Please include attendee names and contact information

Thanuja Naidu is Clinical Operations Manager at Pharm-Olam International's office in Bangalore, India. Thanuja has 18 years of industry experience including roles as QA Manager and Regulatory Manager for a variety of pharma companies including: SmithKline Beecham, Lundbeck, Ciba Vision, and CIPLA.

Her clinical trial experience includes oncology, endocrinology, infectious disease, nephrology, ophthalmology, psychiatry and rheumatology. Thanuja has a Masters degree in Pharmacy.

Dr. Jorge Fiuza is Senior Director of Latin American Operations at Pharm-Olam International. He is a qualified urologist and has over 16 years of experience managing clinical trials throughout Latin America, including management of the phase III trial for Viagra throughout the region.

Before joining Pharm-Olam he served with four multi-national pharmaceutical companies, two SMOs, and two global CROs in the region. He has experience managing over 30 trials across 10 therapeutic areas. His experience involves regulatory expertise, clinical operations, project management across the countries in Latin American region.

Petro de Wet manages Pharm-Olam’s South African operations. She has 9 years of experience in clinical research from monitoring local studies to managing global projects involving South Africa.

Her experience in clinical trials includes: trauma, cardiology, neurology, diabetes, infectious disease, and HIV related studies.

Dr. Anastasya Lukina is a Global Program Director for Pharm-Olam based in Moscow, Russia. She has 9 years of clinical research experience, including managing large global studies for oncology and rheumatology in USA, Western Europe, Russia and the neighboring states of Ukraine, Belarus, and Georgia. Dr. Lukina is a certified cardiologist.

Seminar moderator, Madeline Ducate, MS MPH, is responsible for worldwide operations for Pharm-Olam. Her experience includes over 25 years in clinical research, including serving as Pharmaco/PPD’s VP of Clinical Operations and Project Management for Europe, Asia, Africa and VP of Global Operations for Neeman Medical International, a SMO with locations in the U.S., India, and Latin America. She is also an Associate Professor at the UMDNJ teaching a graduate course on international regulatory requirements.