What Topics Are Covered in the eCTD Publishing Whitepaper?
We look at:
- The options available to the company when considering how best to manage electronic publishing of regulatory submissions. Is it best to centralise everything within the company, allow local offices to manage or to outsource? We discuss the options.
- How do you prepare for PSUSA deadlines? We look at how best to prepare.
- The difficulties associated with in-licencing a eCTD dossier are discussed in this article by Eileen Ryan.
Recent Publications from Acorn Regulatorypharmacovigilance and medical teams work with some of the largest and most dynamic companies in the world. They have looked at the major issues impacting their clients at the moment and have created ‘PV Update’ which is our latest PV e-book.
‘PV Update’ considers issues such as:
- An overview of post authorisation safety studies
- The role of the QPPV after Brexit
- What will a UK PSMF look like?
- The increasing obligations of scientific literature
- Pharmaceutical Development for Historic Dossiers
- Good Pharmacovigilance Practice (GvP) & Social Media
- The EU MDR & The Authorised Representative
- Advice for Companies Attending Scientific Advice Meetings
- What You Need To Know About MRP Grouped Variations