Swissmedic introduces the Preliminary Decision Clarification Meeting for human medicinal products containing new active substances
In the course of the regulatory approval process, particularly for innovative products, situations often arise where a close dialogue with the authority is needed or beneficial, e.g. to clarify specific scientific issues or to agree on a certain response strategy to address (major) concerns that the authority has identified.
AI in Pharma – considerations of Annex 22
Artificial Intelligence (AI) is increasingly being adopted in pharmaceutical industry, offering new opportunities to save time and enhance quality assurance. To ensure these technologies are used responsibly, the European Commission has drafted the new Annex 22 to the EU GMP Guidelines – providing a regulatory framework for AI applications used in the manufacture of active pharmaceutical ingredients (APIs) and medicinal products.
Arex Advisor welcomes Senior Regulatory Affairs Consultant Nathalie Rion
Arex Advisor is pleased to welcome Nathalie Rion as Senior Consultant Regulatory Affairs. Nathalie brings a broad regulatory affairs background across various therapeutic areas. She has successfully led and supported multiple Marketing Authorisation Applications (MAAs), including those for orphan and oncology products.