Melanie Carr – SME sessions at TOPRA Symposium 2009
Q: How did you become involved with this year’s symposium?
A: Following a discussion with Margareth Jorvid, the Chair of the Symposium Working Party.
Q: What role have you played in developing the programme/developing your session?
A: I have discussed content of session and presentation with Margareth.
Q: What are you most looking forward to at the symposium and why?
A: Meeting the SMEs (small and medium-sized enterprises) and hearing about the challenges they face in the current regulatory environment. I am also looking forward to discussing the experience the Agency has had since its SME office opened at the end of 2005.
Q: Why do you think RA professionals should endeavour to attend symposia such as this one?
A: To gain up to-date-knowledge and keep abreast of developments and new initiatives in the regulatory arena.
Q: What is the main message that you would like symposium delegates to go away with?
A: To open up an dialogue with the Agency early in development. This is particularly important for SMEs.
Q: What is the greatest challenge facing regulatory affairs professionals today?
A: Going global.
Q: If you could do one thing to improve the regulatory environment what would it be and why?
A: Improve patients’ access to medicines once authorised.
Q: What are your own priorities/challenges for the year ahead?
A: To further support SMEs in the regulatory framework by reinforcing the provision of information on SME initiatives. To increase dialogue with companies following SME assignment, through strategy briefing meetings prior to application for marketing authorisation, eCTD support, and de-briefing meetings at major milestones in the approval process. To further engage SMEs and their stakeholders to provide feedback on new regulations, guidelines and procedures (eg, for Advanced Therapy Medicinal Products).
Q: On a personal front, who has influenced you most in your career and why?
A: My pre-registration tutor in pharmacy who got me involved in regulatory affairs.
Q: Can you tell readers one thing that they wouldn’t know about you – and would be surprised to know?
A: I have never been to Stockholm before and I am very much looking forward to visiting.
