Regional alignment in Asia Pacific: What needs to be in the regulatory science toolkit to enable good regulatory decision making?
26-27th January 2011, Tokyo, Japan
Regulatory agencies are rising to meet the challenge posed by the reality in which companies are not only undertaking global clinical trials but are also looking to make their products available to patients worldwide in a timely, often almost simultaneous fashion. In the developing pharmaceutical markets this has put pressure on the evolution of regulatory policy, infrastructure and resources, while in established markets resource implications along with the duplicative nature of some of the work is resulting in an increasing emphasis on collaboration and sharing of resources where possible.
As more agencies look to take a science-based approach to regulation and risk-based decision making, a common regulatory language is being developed as well as clarity around the resources required to approve and monitor new medicines. This has lead agencies to begin to discuss and work out how to cooperate in order to share information and activities, such as safety data and inspections, as well as exchange of staff. In addition, some agencies are looking to the exchange of assessment reports. Challenges to collaboration include differences in skill sets, experience and processes between agencies.
The key question therefore is, what are the underpinning components of good regulatory decision making and what are the regulatory science tools that can be used to ensure a timely, high-quality, predictable and transparent process whilst ensuring an effective and efficient use of resources?
Workshop objectives
- Discuss good risk-based regulatory decision making and what the components are that need to be built into the review process.
- Identify current initiatives/approaches and understand how these are enabling the decision making process from companies and agencies perspective.
- Recommend what should be in the regulatory science “toolkit” and how best this can be used as part of the regional alignment initiatives.