Ivowen Limited can provide Regulatory Affairs Overview Training to all interested parties. This will provide an insight into the function of Regulatory Affairs, why it is necessary, what is required to support the Regulatory function and what Regulatory Affairs departments need from other departments to make projects a success. Also included is comprehensive, specialised training in all aspects of the EU legislation and in the MRP/DCP/CP and CTD systems for registering generic drugs in the EU, which is our speciality.

Training includes:

  • Full text notes including suggested wording for certain sections of the dossier
  • Case studies tailored to your level of knowledge
  • All relevant and current guidelines for each section


pharma med-devices pharma-vigilance training