Covering Latest Developments and Hot Topics – consolidate your understanding of the issues that challenge companies in the current regulatory environment
This advanced course has been specifically designed to provide an update on the latest developments impacting on your role whether you work in pharmacovigilance or an associated function. In particular it will look at the progress with the ‘new’ EU legislation, how it is being interpreted and implemented by industry, the regulators and inspectors.
The programme will include discussion and interpretation of the most current EU legislation as well as covering topical current issues relevant to pharmacovigilance. There will be ample opportunity throughout the two days for discussion, tips and practical advice from the expert speakers and co-delegates. You will also be welcome to contribute your own experiences.
The programme will also cover core topics, with the topic selection based on areas of pharmacovigilance where inspection findings commonly occur. Delegates will also be offered some ‘hot topics’ that have been in the news recently. Your input will be requested prior to the course to decide what topics are included in the final agenda.
This interactive course will benefit you if you are involved in the daily practice of pharmacovigilance and are looking for an update on the latest developments and current ‘hot topics’.
It will also benefit those in departments working closely with the pharmacovigilance department, such as regulatory, clinical, medical information or quality. It will help you understand what they are asking for from you and why, enabling you to work more effectively with them.
The following core topics will be covered:
GVP Module I and Quality System – approaches and challenges
Your input will be requested prior to the course to select the topics of most value to delegates. Select from the following topics or please propose a topic or focus of your own.
Please note that it may not be possible to include all topics proposed.QPPV oversight
Reference Safety Information
Literature – Global and Local requirements