Solomon K. Sackitey, International Regulatory Affairs Updates
14 April 2008
For the next couple of days, the Mandalay Bay Resort and Casino in Las Vegas, Nevada (USA) will take center-stage not for a World Heavyweight Boxing match but for heavyweights whose current thinking could have a major impact on the future of drugs, biologics and medical device design, clinical trials, regulations, labeling and pricing.
One of such speakers, Jethro Ekuta (DVM, PhD) of Nigeria
, is an expert on Pediatric Drugs Development and Regulation. His presentation in the Pediatric Clinical Trials Symposium
is captioned “Regulatory changes and requirements: we have the rules, now how do we play?”. His other speaking engagements on pediatric
drugs development and clinical trials
include the 2008 Regulatory Affairs Professionals Society (RAPS) Annual Conference
where he will be making presentations on, Pediatric Drug Development, and Post-marketing Requirements for Drugs, Biologics and Medical Devices.
In Las Vegas, Dr. Ekuta will be addressing, among other subjects, the following questions:
- Where is the industry headed? How will regulations play out?
- How are the recent legislations going to play out from a drug development perspective?
- How do you incorporate the recent regulatory requirements into your clinical plans? How fine-tuned do your plans need to be?
- With the new laws in place, how do we work within the context of both the EU and US regulatory environments?
- If you are trying to develop pediatric programs that work, what are the critical elements of strategy for a global pediatric program?
- What role do regulators (i.e. FDA, EMEA) have in enhancing global pediatric development?
Other speakers include Earvin ’Magic’ Johnson, a former basketball player of the Los Angeles Lakers and a 2002 Basketball Hall of Fame inductee who will be making a speech during the 17th Annual Partnerships with CROs meeting.
As a prelude to the 17th Annual Partnerships with CROs Conference, the Institute for International Research
and other organizations have scheduled a number of symposia and workshops beginning today.
These include the Pediatric Clinical Trials Symposium, the12th Annual Electronic Data Capture (EDC) Pre-conference Workshop, the 5th Annual Project Management for Drugs and Device and the Vaccines Development Forum.
Per scheduled agenda, the Las Vegas Convention will seek to address the following in addition to other contemporary issues:
Pediatric Exclusivity Trials: lessons learned from the field
Patient Recruitment and Retention Strategies
Trial Design Considerations
Practical and Ethical Considerations to Expedite Your Drugs to Market
Advancing the Discipline of Managing Clinical Trial Data Using EDC
The Top Ten Challenges Cited By Scientists in Vaccines Development
Powering Up For the Challenge: Innovation, Consolidation and Globalization in Drug Development Partnerships
Innovative Enterprise: Global Sourcing and Pharmacovigilance—Establishing Collaborative Partnerships to Enhance Efficiency, Flexibility and Patient Safety
In view of the global nature of these presentations, at the end of this year’s conference, the meetings are expected to be of immense value to the global health market in general, more so, when Emerging Markets are gaining significant attention in a global economy.
A recent report by IMS Health
indicates that emerging markets will be a major force to recon with in the pharmaceutical industry where sales are projected to be in the neighborhood of $400 billion by the year 2020. This report points out a 12-13% growth per year in countries including China, India, Brazil, Russia, Mexico, South Korea and Turkey whilst single digit growth in the highly industrialized countries is projected.
The much neglected African market has been enjoying significant economic growth of late and is a potential fertile economic ground for outsourcing clinical research and pharmaceutical raw materials manufacturing ( see here
In the Medical Device industry, while Global Harmonization Task Force (GHTF) founding members, US, EU, Japan, Canada, and Australia countries enjoy a formidable export values, a prominent competition from the emerging markets of the Pacific Rim, East Asia, the Middle East, and South America are imminent. The US export markets in the Medical Device industry, according to a recent study
, have an 89 % share or $35 billion of the global $40 billion value.