With the recent publication of the European Commission proposal for a new pharmaceutical legislation, changes in the Variations Regulation, big developments in the digitalisation and several new areas to discover as environmental risk assessment, artificial intelligence and big data, this Conference will be a timely and unmissable opportunity for attendees to be informed about those development and its impact on future day-to-day regulatory operations and on the long-term implications for the off-patent sector in the coming decades.

The conference will bring together key stakeholders, including leading regulators, industry experts, and European institution officials, to engage in discussions & debates on the regulatory challenges and opportunities that lie ahead.

Highlighted areas of discussion on the revision of the pharmaceutical legislation include:

• Looking to the future – What changes can we expect in the coming years in the pharmaceutical environment?
• What’s new in the Revised Variations Regulation?
• Union List of Critical Medicines- what are the implications for products being on the list?
• Regulatory affairs fitting with the digital age – what is the journey and how to be prepared
• Leveraging new technologies in regulatory science – how can it help off-patent sector?
• Changes to the Product information in view of the new QRD template and the revision of the Pharmaceutical Legislation – what could be practical implications?

The conference will end with a special brainstorming session on possible improvement in predictability of submission in the DCP and MRP and what could be done to better plan and use limited resources?

In addition, participants will have access to three on-line technical webinars focusing on:

• Shortage reporting and implementation of European Shortage Reporting Platform
• Environmental Risk Assessment (ERA) – implementation of the revised EMA guidelines on ERA and possible changes linked to the review of EU Pharmaceutical legislation
• The latest developments in the pharmacovigilance spaceData Integrity in Bioequivalence
  Studies

Don’t miss this opportunity to join regulators, industry experts and policymakers in a lively debate on the future of regulatory affairs in the European pharmaceutical industry.