Curriculum

Headed the Japan specialty and generic R&D project development at Teva from 2007. In this function operated and managed teams in branded and Generic R&D for submission of global clinical project teams atPhase I - III drug developments, resulting in more than 100 approved ANDA submissions, 1 NDA and numerous Phase 3 trials in Japan.

Services

A training program is additional unique service, offered to companies that want to explore their suitability entering the Japanese market, or extending their foothold in Japan. A tailor-maid training program is designed to meet the needs of the customer in fields of market access, development, production, submission, audits and others.  

The learning objectives are customized to the specific needs of our customers to enter successfully the Japanese pharmaceutical market, or to gain a foodhold in the Japanese market. 

THE learning content covers the cultural, regulatory and specific technical requirements of the Japanese market

This structured training program is design to address the key expectations of a market entry, business case, and potential regulatory or customer audit for compliance, completeness and effectiveness.

Held in English/Hebrew/German the program can be extended to project support in entering and finding suitable partners in the Japanese market.

On-demand tailor-made training Programms

• A thorough overview and in-depth case studies on how to successfully navigate the Japanese health authorities and introduce pharmaceutical products onto the Japanese market. 
• The do's and don'ts of constructive interactions with Japanese colleagues and officials
• The participant will become familiar with the contents of drug files, and the Japanese regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). 
• The regulatory procedures will be discussed throughout the drug development phases and how to successfully consult with PMDA, e.g, in the clinical trial notification phase. 
• Latest trends in Japanese pharmaceutical regulations and procedures. 
• Understand the Japanese drug development and post-approval framework and regulatory procedure in CMC, clinical and regulatory audits.

Training Recommended Core Content

The training will be adjusted to meet the customer requirements and will include among others the following topics:

1. Introduction to Japanese marketplace
2. Culture differences and points to avoid while negotiating with Japanese customers/regulatory bodies
3. Introduction to the Japanese regulatory bodies
4. Sakigake system
5. Strategic consultations
6. Clinical trial notification
7. Clinical studies and GCP in Japan
8. Japanese new drug application: submission and approval
9. Generic drug regulation in Japan
10. Introduction to JP pharmacopeia and major differences to USP/Ph. Eur.
11. DMF registration requirements
12. Analytical methodology requirements in Japan
13. Reference standards
14. Reagents and Solvents
15. PMDA GMP audits and compliance review