ICH Regulation and Compliance in China:

When it comes to ICH regulations, China is in an exciting phase of change. Organizations must be in compliance with the regulations by 2019, and knowing whether your current provider gives you what you need should be assessed immediately. Even though the CFDA have delayed the E2B R3, in order to be compliant by 2019 then decisions about your safety and pharmacovigilance (PV) system need to made today.

To compound matters, the Chinese PV market is growing extremely fast; even just in the last few months new PV vendors have emerged and are trying to capitalize. Therefore, switching to a new PV provider can throw up some big challenges, including:

• What criteria should be used when selecting/evaluating a PV system?
• What is the highest priority: cost? quality? time to implement?
• How can you know if the system and gateway is truly validated?

There are some bold claims being made by vendors which can be misleading or open to interpretation. However, during this webinar we will help to support your decision-making criteria, identify what you need to consider in your selection, to ensure that not only are you complaint today, but also for tomorrow and in 5 years’ time.

During this webinar you will learn about:

• The latest ICH regulations and compliance
• The potential impact of these regulations both now and in 2019
• Selection criteria when choosing a vendor
• Justifying the need for ensuring software and gateway validation