This hot topic day will take stock on the first experiences with the new pharmacovigilance legislation and will present views and perspectives from regulators and industries.
The Phamacovigilance legislation came into force by 1.1 2011 and applies from July 2012.
The new legislation is considered to be the largest change in human regulatory medicine since 1995. The implementation of this legislation is therefore a huge challenge for all stakeholders - the EMA, the national agencies and the pharmaceutical industry. While the preparation of the new legislation lasted several years, the implementation phase is rapid and intensive. Within a short timeframe the pharmaceutical industry has to revise key processes in accordance with the wide range of legal provisions, implementing measures, transitional arrangements and guidelines.
Ongoing dialogues between industries and legislators are therefore crucial to ensure a smooth implementation of this important legislation.