Working Environment
List of Specialist Education Courses by Job Category
WORKING ENVIRONMENT
We provide training courses designed to impart the knowledge required to excel in each job category. From basic training for persons with no experience to leadership development education, our teams of experts implement diverse training programs. Through conducting specialist education for deepening and establishing expertise, we continue to lay the foundations so that human resources from various backgrounds, whether they are from sciences or humanities, can work productively.
Clinical Research Associate
- Teams of experts implement training in 9 specialist fields (cancer, regenerative medicine, etc.)
- Leaders' Training
- Training for Clinical Leaders and Clinical Research Associate who are first assigned to global projects, in particular ICCC studies*1.
- Ongoing training for Clinical Research Associate are conducted by department task forces.
*1: ICCC (In-Country Clinical Caretaker): An organization that conducts all clinical development activities in Japan on behalf of clinical trial Sponsors (foreign pharmaceutical companies), in cases where the Sponsor has no local entity in Japan.
Data Management
- Leader Development Training
- Leader Training (Coaching/Management/Human Resources Development)
- Data Management Officer Training, System Engineer Officer Training
- External training programs on Real World Data (RWD)*2, e-Solution, etc.
- External training programs on the latest industry trends (Risk Based Approach, Decentralized Clinical Trial, etc.)
*2 Refer to various data accrued in medical settings, such as electronic medical record data, medical examination data, etc.
Statistical Analysis
- Leader Development Training
- Leader Training (Coaching/Management/Human Resources Development)
- Statistical Analysis Officer Training
- External training programs such as Bios/CT and other external statistics seminars
- In-house training conducted by external lecturers
- External training programs on Real World Data (RWD), epidemiology, PK/PPK and other statistics-related topics
- Assistance for advancing to graduate school studies
Pharmacovigilance
- MedDRA Coding Training
- Ongoing training on updateses in Japan/EU/US regulatory requirements medical and pharmaceutical affairs
- Training on PMS (post-marketing surveillance) for Pharmacovigilance writing (safety periodic reports, etc.)
Project Management
- Off-site meetings (once/year) for improving Project Management skills (case studies, introduction to project management, etc.)
- Training for improving negotiation skills with overseas clients
- Voluntary study groups for improving Project Management skills
Regulatory Affairs Consulting
The following training programs are held occasionally as appropriate. Past training archives are also available for self-training.
- Medical Writing Training (beginner, intermediate, advanced)
- English Writing Training
- Statistical Analysis Training
- Guideline Training
- Review Report Training
- Project Case Studies
- Sharing summary and feedback from seminars/symposiums, etc.
