pharmabio consulting

Regulatory Affairs Training Part 2


Mastering EU Requirements for Product Information: SmPC, PIL and Labels
This interactive 1, 2- or 3-day course will clarify the European regulatory requirements for developing the physicians SmPC, and how to derive the package leaflets and labeling to satisfy readability and compliance. Develop tools for testing the readability of your PILs.

  • List adverse reactions without negatively impacting patient compliance
  • Develop a labelling strategy at an early stage of your product registration process
  • Implement practical steps to successfully work with your marketing team
  • Know what should be on a leaflet/carton/label
  • Review your legal liability
  • Utilise data for maximum clarity
  • Understand the requirements for provision of patient information in Europe

European Regulatory Affairs
The course will empower you at the Advanced or Fundamental level as requesgted with the tools required to successfully navigate the minefield which is European regulatory affairs. It also compares and contrasts regulatory requirements between Europe and the USA so that you can devise either an optimal harmonised or at least aligned international development.
This course will provide you with a clear understanding of the EU regulatory structure and ensure that your submissions meet the standards required by the regulators.

Registration of Pharmaceuticals in the EU

  • Comply with the regulatory requirements for EU dossier submissions.
  • Build and manage successful marketing applications.
  • How to deal with Variations in your CM&C cycle.
  • Requirements for generic and abridged applications.
  • Clinical and Non-clinical dossier requirements.

Insights into the FDA and Leveraging EU/US Regulatory Opportunities for Approvals
Achieve faster drug registration in the US. The requirements, expectations and regulatory aspects of the FDA for approval. Successful Investigational New Drug Applications (INDs) avoiding clinical holds to New Drug Applications (NDAs)

Fundamentals of Pharmacokinetics
This half or one day course will provide the essential understanding you need to work with PK data or interprete PK findings in a regulatory context. It can be at basic, medium or advanced level. Trainer is a clinical pharmacologist industry consultant (ex-major CRO 14 y) and academic lecturer, with over 26 y experience with PK and PD of NCEs by all routes of administration and over 10 y biologics.

Your experts in Drug Development and Global Regulatory Affairs.