K e e p i n g
y o u
O cto b e r 2013
T h e T O P R A N e w s l e tt e r – K e e ping m e m b e rs in T o u c h
In this issue... Following the lull of the summer months, and now that everyone is back from their holidays, there seems to be a frenzy of activity. TOPRA is no exception. There’s the TOPRA Annual Symposium which has just taken place – look out for coverage in next month’s InTouch. We are now looking forward to the Awards for Regulatory Excellence which will be held next month. I’d like to take this opportunity to congratulate the shortlisted nominees (see page 2). It’s your opportunity to vote new members to the Board in the next few weeks. Please find out more about the candidates on page 3. Looking to the future, I’ve spotted that TOPRA’s ever-growing membership is becoming increasingly global. With new members from as far as the United Arab Emirates, Malaysia and Australia – welcome to you all! Greer Deal, Co-editor, InTouch
Have your say
A message from Patrizia Nestby, TOPRA President It is a very busy time of year for TOPRA with the Annual Symposium, the Regulatory Affairs Awards and, most importantly, for every member the TOPRA Board Elections. This year we have elections for both President Elect and four Directors. For full information on all the candidates and the election process go to page 3. The elections are your opportunity to have a say in the composition of the TOPRA Board and how our organisation will take shape in future. I encourage you to cast your vote!
NEWS FROM THE TOPRA MEMBERSHIP TEAM
In this month’s column, Head of Membership Duncan Judd focuses on networking via the Special Interest Networks (SPINs) TOPRA members are very passionate about regulatory affairs and this enables us to continue to develop our networks that bring members together. TOPRA Special Interest Networks are one of the main benefits of membership. They create an environment to facilitate neutral and independent discussion within a face-to-face or virtual context. We have active SPINs for Clinical Trials, CMC (Chemistry, Manufacturing and Controls), Electronic Regulatory Affairs, Med Tech, Pharmacovigilance, Regulatory Intelligence and Veterinary. Taking part in SPINs, and volunteering in general with
TOPRA, helps members both gain insight into regulatory issues from their peers as well as give back to the profession by sharing knowledge and forms of best practice that can assist other members in their regulatory roles. Members really value the ability to become part of a community of professionals that has an identity and respect. A recent Med Tech SPIN meeting in the TOPRA office, for example, produced a day of keen discussion. On the same day, a virtual VET SPIN meeting was held remotely for vet members. I am assisting with the development of all our networks and this will be facilitated by a new database and website. By early
TOPRA In Updates
2014 members will be able to see the benefits of this new approach. It will enable members to interact with others in the same networks, instant messaging for Q&A, access to meeting dates, downloadable information and minutes and will allow members to join any of the networks they wish to. If you want to know more about how to join a SPIN, or TOPRA In group, or for information on what they involve and when their next meeting dates are then please e-mail me at duncan@ topra.org. I look forward to updating you all on the next stage of developments with your membership soon.
A recent TOPRA In Switzerland networking event at switzerland Clinipace, Zurich brought TOPRA members together from all over Switzerland and the surrounding regions for an evening of networking. There were discussions on the challenges of managing eSubmissions and implementing eCTD in Global Organisations, while representatives from the local agency Swissmedic also discussed issues. The event was a great success and was followed by informal networking for all TOPRA In members. The next TOPRA In networking meetings are due to be held in Dublin on 22 October for TOPRA In Ireland, along with an international TOPRA In event to be held in Austria on 14 November for members in Austria, Sweden, Italy, France, Spain and Portugal.