S.E. Asia Drug/Device Update: Market Potential and Regulatory Environment

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Medical Device, Emerging Market, Medical Device Safety and Regulation,
  • Thursday, June 06, 2013


Clinical research in Southeast Asia, as well as positioning for product registration and commercialization, is increasingly central to multinational drug development programs
. The S.E. Asia region combines many of the elements western sponsors require including: vibrant urban healthcare system, English as the business language, first rate medical credentials of Investigators and progressive Regulatory to ensure quality data and patient safety.

Commercialization is key, as the region is home to 60% of the world’s population and growing rapidly; expected to exceed 5.6B by 2050. There is a growing educated middle class suffering from ‘western’ diseases because of economic prosperity so they’re therefore more interested in health and aging issues, benefitting clinical research development.

  • It has been anticipated that S.E. Asia’s pharmaceutical and device market could reach a size of $20B by 2015, becoming one of the top 10 drug markets in the world.

The S.E. Asia region offers a venue for faster recruitment and more cost effective trials in addition to rapidly growing markets for product registration and commercialization to the over 1.5B population size.

Join us for this live event with interactive Q&A as we discuss:

  • Clinical research scenario in S.E. Asia
  • Market opportunity, registration
  • New regulatory & safety guidelines

Speakers

Dr. Shariq Anwar, Head of Operations, Max Neeman International

Dr. Shariq has been with Max Neeman for over 13 years and plays an integral role overseeing Operations and Regulatory Affairs for the company.

He’s been associated with many global clinical research programs and has been working closely with various KOLs in the process of drug development.

Message Presenter

Donald Swankie, MBA, Vice President, USA, Max Neeman International

Mr. Swankie is responsible for the territories of North America and Latin America at Max Neeman. He has twenty years business development and consulting services experience with many in Life Sciences and Clinical Research, in both Biotechnology and U.S. Public Health care forums. Past companies he worked for include Quintiles Transnational and Science Application International [SAIC].

Mr. Swankie holds a Masters Degree from Wake Forest University Babcock Graduate School of Business, 1995. He also holds a BSBA in Business and Economics from St. Peter’s College. He has an Executive education in Life Sciences, Duke University Associated with Max Neeman International for 4 years.

Message Presenter

Who Should Attend?

Professionals from pharmaceutical and biotechnology companies with responsibilities and interests in:

  • Market Access Emerging Markets – Southeast Asia
  • Business Analysis and Development
  • Finance
  • Legal, Regulatory & Government Affairs
  • Sales & Marketing
  • Strategic Planning
  • Clinical Operations

Xtalks Partner

Max Neeman

Max Neeman International is a leading Contract Research Organization and the wholly-owned clinical research subsidiary of Max India; a reputed business group which also includes Max Healthcare hospitals, health and life insurance organizations. For over a decade, Max Neeman has offered customized services to global Pharmaceutical, biotech, device and nutraceutical companies in the conduct of drug and device trials. Data Management and Medical Writing services alone have touched 60 countries to date. Operating since 2001, Max Neeman is ISO certified for Site Management, Monitoring, Data Management, Information Security Management Systems and Clinical Investigation of Medical Devices with 6 regional offices, 200 sites across 43 cities, headquarters in New Delhi and RTP North Carolina based USA office.

Max Neeman has been awarded 305 trials and 80% of >400 employees are M.D.’s trained in ICH GCP guidelines.

Services include:

Project Management
Regulatory Submission
Site Monitoring
Clinical Data Management
Biometrics and Report Writing
Site Management
Device Importation, Warehousing & Distribution

Media Partner

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account