Course: Navigating Japan’s Biotech and Pharmaceutical Market

This comprehensive course provides in-depth training on the following areas:

• Japan’s Regulatory Landscape: Understand Japan’s complex regulatory environment, including the role of the PMDA (Pharmaceuticals and Medical Devices Agency) and how to achieve product approvals.

• Japanese Good Clinical Practice (J-GCP): Learn the ins and outs of J-GCP and how it differs from international GCP standards.

• Cultural Competence and Business Etiquette: Master the key elements of Japanese business culture to build strong relationships and partnerships.

• Market Entry and Growth Strategies: Develop a strategic approach to entering Japan’s biotech and pharma markets, including overcoming common entry barriers.

• Japanese Language Skills for Pharma Professionals: Essential language tips to help you communicate effectively in the Japanese market.

This course is ideal for:

• Regulatory Affairs Managers

• Business Development Executives

• Clinical Trial Managers

• Pharmaceutical Executives

• R&D Managers

• International Expansion Teams

Whether you’re planning to enter the Japanese market or enhance your existing operations, this course provides the vital knowledge to succeed.

Start Date: 14 October Duration: 16 hours (spread across 4 weeks, 2 hours per session) Time: 16:00 - 18:00 (Mondays and Thursdays)

By the end of this course, you will:

• Gain a deep understanding of Japan’s regulatory framework and approval processes.

• Develop cultural competence, enabling better communication and relationship-building with Japanese partners.

• Learn how to navigate the PMDA and ensure compliance with J-GCP standards.

• Understand key strategies for successful market entry and expansion in Japan.

Austin Westerman-Gritli, PhD With over 15 years of experience working in Japan’s biotech and pharmaceutical sectors, Austin brings unmatched expertise in regulatory compliance, cultural fluency, and business strategy. His mission is to empower international companies to succeed in Japan’s complex market.

Secure your spot in this course by registering today. Early bird discounts are available for a limited time!