Pharmaceutical Regulatory Affairs Summit
Session Topic: “A Guide for Smaller Enterprises: Bringing eCTD Publishing In-house”
- How to know it’s time to move publishing in-house
- Questions to ask potential vendors
- Ensuring the success of those critical first submissions – ensuring staff are supported
- Future scalability considerations
Speakers
Sandra Vignes
Technical Solutions Director
A pharmacist by training, Sandra works with clients and internal teams at Calyx to devise and implement world-class solutions in Regulatory Information Management, Publishing and Electronic Regulatory Submissions. She has 28 years’ experience in Pharma, including 17 at Merck, Sharp & Dohme, in Belgium and her native Australia. Since moving to the UK, she has also worked for ArisGlobal, where she worked as a Subject Matter Expert and Solutions Engineer in RIM. Much of her career has focussed on systems and processes in regulatory affairs, along with some experience in clinical research and medical information. Sandra holds a Bachelor of Pharmacy from the University of Sydney and a Postgraduate Diploma in Drug Development from the University of New South Wales. She is currently a candidate for a Master of Science in Public Health at King’s College London.
