Overview of the Medical Device Development and Commercialization Process and Steps for Success
★What cannot be done with animal evaluation and clinical evaluation ★Clear up issues related to regulations such as the Pharmaceutical Affairs Law, GLP, GMP, clinical evaluation, GCP, pharmaceutical applications, and health insurance applications.
Seminar Number S10602 Instructor Takashi Kawabata, Representative of the Medical Device Technology Information Association (Formerly of Nippon Zeon) Target Audience Newcomers and beginners involved in medical device development and commercialization, as well as veterans looking to review. Venue Kawasaki City Industrial Promotion Hall, Conference Room 1 [Kanagawa, Kawasaki Station] - 6 minutes on foot from JR and Keikyu Kawasaki Station Please note that the venue may change to a location in the Tokyo metropolitan area due to scheduled power outages. We will notify you one week prior to the event date. Thank you for your understanding. Date and Time June 16, 2011 (Thursday) 12:30-16:30 Capacity 20 participants - Please apply early as there may be a rush of applications. Participation Fee 49,350 yen (including tax and text costs) for up to 2 participants from one company. *New members who apply for the first time by June 2 will receive an early bird discount price of 44,100 yen. ◆ Early Bird Discount: Please select "1 slot for 2 participants: Early Bird Discount" when registering. ◆ For additional applications from the same organization, an additional 12,600 yen will be charged per participant. ◆ Information on subsidy programs related to seminar participation fees.
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basic information
This seminar is aimed at engineers and managers who are tackling the field of medical devices for the first time, as well as those with limited experience in medical devices. It will provide a broad overview of the basic procedures and rules of medical device development, introduce key points for addressing challenges, and present available development infrastructure. Before delving deeply into the subject, participants will gain a fundamental understanding to confirm the "veins of medical devices," ensuring they do not lose their sense of direction and can achieve efficient development.
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. Introduction 2. Characteristics of the Medical Device Business 3. Theme Selection and Decision 3-1. Theme Selection and Probability of Development Success 4. How to Build a Development Organization 4-1. How to Select Project Leaders and Members 4-2. How to Create a Regulatory Promotion Organization 4-3. Importance of Marketing Organization and Its Assurance 5. Development and Development Management 6. Concept and Effectiveness of Basic Studies 7. Animal Evaluation and Its Concepts 7-1. What Can Be Done in Animal Evaluation and What Cannot Be Done in Clinical Evaluation 7-2. Conducting Animal Experiments Cost-Effectively and Efficiently 8. Concepts and Approaches to Clinical Trials 8-1. Clinical Trials and Their Significance 8-2. GCP and Selection of Clinical Facilities and Clinical Evaluation 9. Concepts of Regulatory Submission 9-1. When is the Approval Application Form Created? 9-2. Meaning of the Application Form and How to Create It 10. Production Start-Up and Quality Assurance 10-1. Manufacturing Policy, Factory Design, Manufacturing Management, and GMP Concepts 10-2. Points to Consider for Production Start-Up and Quality Assurance 11. Concepts and Methods of Sales 12. Key Points for Business Success
Company information
Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.
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