Candidates for the position of Director with special responsibility for Europe on the TOPRA Board.

The following candidates all stood for election, but only ONE can be elected. Please read the information the candidates have supplied in support of their nomination and select the one you think should get your vote.

Paolo Biffignandi

I have been working as a regulatory professional and medical writer since more than 20 years, well before the EMA was founded and the current legislation was created.

I served ESRA for a long period in the past, then TOPRA for seven years, as Editor of Regulatory Rapporteur, member of the Board and President in 2009-10.

This experience gave me the full perception of the immense value of our organisation.

After the Annual Symposium in Rome last year, which I had the privilege to chair, I realised how poorly known TOPRA is in some European countries and how the organisation can be immediately appreciated and valued once it is introduced in different cultures in Europe.

My contribution, if elected, will focus on strengthening the perception and presence of TOPRA in Europe, along the strategic lines of the Board, the enthusiastic help of the volunteers in the many ‘TOPRA In..’, and the friends and colleagues at the office.

Click HERE to cast your vote.

Aaron Cousins

A highly motivated and enthusiastic individual with 17 years’ experience in the field of Medical Device Quality Management and Regulatory Affairs. Currently working for Becton Dickinson as Associate Director Regulatory Affairs, EMEA in the Preanalytical Systems business unit.

With a broad experience of all aspects of Regulatory Management including CE marking, standards development, manufacturing quality, vigilance, risk management etc., I have a keen interest in the post market phase and in particular the relationship between post-market decision making and risk management. Having completed the TOPRA / Cranfield MTRA MSc I am also keen to promote the development and uptake of this course and to help establish other vehicles for the education and development of regulatory professionals working in our industry. TOPRA's role in the development of our skills and the promotion of our profession is key and as a member of the board I would aim to drive further success in these areas with a particular focus on increasing the organisations' presence and impact throughout Europe.

A father to two beautiful young girls (and therefore an expert in conflict resolution), I currently live and work in Oxford. Although free time is scarce, I enjoy swimming, working out in the gym, playing tennis and listening to live music.

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Aine Kane

I bring 17 years experience in the pharmaceutical industry (9 years in analytical research and 8 years in a regulatory position). During this time I have developed an in-depth knowledge of regulatory submissions (clinical trials, global marketing applications, post approval and compliance), in meeting with regulatory agencies (EMA, FDA and European agencies) and in engaging in the external regulatory environment.

I have been actively involved in TOPRA where I have contributed at a number of levels. For the last 2 years I have been the EU representative on the board and in this capacity have worked with the TOPRA office in setting up a number of TOPRA-In groups in Austria, France, Germany, Ireland, Italy, Sweden and Switzerland. The TOPRA-In initiative serves the needs of Regulatory Affairs professionals living and working in countries by providing an informal forum for networking, meetings and discussion at a local level.

Prior to this I was chair of the TOPRA CMC SPIN for over 2 years, and continue to be on the CMC SPIN steering committee as well as chair of the 2010 CRED CMC working party and a member of the Regulatory Rapporteur editorial team for a number of years.

Having been an active volunteer of TOPRA through the CMC SPIN, Regulatory Rapporteur editorial team and on the board for the past 2 years, I have had an opportunity to understand the organisation and the benefits it presents to professionals in the regulatory arena. With this knowledge and experience, my past commitment to the organisation and current active contribution I believe I can continue to assist TOPRA through my membership of the board. I would be delighted to be able to continue to contribute to the work of TOPRA and grow the TOPRA-In groups as the TOPRA EU board representative.

Click HERE to cast your vote.

Shekhar Natarajan

I have over 14 years of industry experience within Regulatory and Quality working for companies like J&J (UK), GSK (UK) and UCB (UK). I am currently working as Assistant General Manager -Regulatory Affairs with Biocon Limited in India. My responsibility within Biocon is to support registration of medicinal products in Europe, US and Emerging markets. I hold a Master’s degree in Pharmaceutical Sciences from the UK.

Over the last few years, apart from my day to day function within RA, I have been extensively involved in representing employers/trade associations in meetings with EU regulators on regulatory and technical matters. I have also been invited by companies like IBC Life Sciences and Informa to deliver presentations on regulatory and CMC issues. I have also visited UK universities as guest lecturer to deliver presentation on regulatory affairs. I also chaired the DP part of TOPRA CMC CRED workshop in 2010. Other than TOPRA, I am also a member various scientific and professional bodies like Royal Society of Chemistry (UK) and Regulatory Affairs Professional Society (USA).

If given an opportunity to serve as TOPRA Board member, I would like to utilize the experience I have gained over the last several years in supporting TOPRA’s vision of raising the regulatory profile and promoting the profession as a whole. I would also like to utilize my experience of representing employers and trade associations in meetings with EMA, EDQM and CMDh to discuss on technical and regulatory matters which I can do more efficiently by being part of TOPRA Board. As I have also been part of training and education programs as mentioned above, I can also help TOPRA in its vision to provide high quality education and training to individuals in their career development.

Click HERE to cast your vote.