RSCI 604 “Regulatory Strategy in Asia” (4 units)
Are regulatory standards developed and applied in different constituencies in Asia? At the beginning of the course, we will study in depth the regulatory rules and business climate in countries that differ markedly in their levels of development, regulatory maturity and socioeconomic features. Students will develop briefing packages on the different countries for the use of their colleagues. We will then travel to a subset of Asian countries as a delegation. By meeting with the principal regulatory authorities in each country we will have a first-hand opportunity to study the interplay between culture, management methods and regulatory expectations. We will then visit “typical” domestic and foreign medical-products companies to investigate what they see as the major challenges in medical product development and commercialization. We will explore how regulatory expectations affect principles and practices in the delivery of health care and the expectations of society. We will also examine the stresses that are occurring in these rapidly evolving business environments, and consider approaches and solutions to working with Asian manufacturers and distributors.
RSCI 605 “Managing Organizations and Human Resources” (3 units)
The objective of this course is to study the way that people are organized and managed in organizations of different types and sizes. The course will focus first on management principles in general. We will consider the theoretical underpinnings of personnel management, organizational design and industrial relations. We will then bring that theoretical knowledge into practical situations, using case studies, discussions and role-playing. As part of this course, we will focus on management styles, leadership and negotiation capabilities. Particular attention will be paid to two types of very different organizations, the small, rapidly growing enterprise and the large, mature company with extensive global operations. Such organizations best typify the medical products industry.
RSCI 608 “Regulatory Strategy in Europe & the Americas” (4 units)
The purpose of this course is to acquaint students with the way in which regulations, laws, culture and business climate combine to affect the competitiveness and business environment for medical products in the EU, Canada and South America. The course builds upon a basic understanding of global regulations. Through both focused lectures and later travel to both EU and Canada, students will have the opportunity to talk to representatives of principal policy and rule-making bodies of the European commission and the individual countries themselves. We will study the way that regulations differ from elsewhere in the world and we will further study the differences that exist between the way that foods, drugs and devices are managed in Europe, Canada and South America.