THE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCH

December 2015

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

By the time you read this I will be halfway through the final month of my TOPRA Presidency, which for me highlights just how quickly a year can fly past.

Personally, it has been a huge year for me and my daughter Erin will be 7 months old on Christmas Eve – sadly she does not yet understand the whole excitement of the festivities but I am making up for that on her behalf!

The Annual European Medicines Agency Review of the Year and Outlook for 2016 meeting in November was very successful (see page 3). It was wonderful to see so many colleagues at the event representing the EMA, national authorities, industry and consultants. Delegates were treated to an excellent two-day programme that concluded with an open round table discussion.

Now is a great opportunity to reflect on your goals and

achievements over the past year and to plan new goals for the following year – be they personal or professional.

With that in mind this issue of InTouch details several ways to enhance your professional career, either with a formal educational offering such as the MSc Regulatory Affairs programme, or by getting involved with shaping the career path of those who are new to the regulatory profession.

On this note, I would like to continue to encourage everyone to get involved in your professional membership organisation in any way possible. It is a great way to network, to give back to the profession and importantly to help sculpt regulatory affairs in the future.

I would also like to take this opportunity to wish Thomas Kühler every success in his role

as TOPRA President for 2016, and I look forward to working with him and all the other Board members in continuing to ensure the success of TOPRA as we head into 2016 and beyond.

Finally, I would like to say a huge thank you to all the volunteers who have committed their time and expertise in 2015. These people, dedicated to their profession, ensure we have the drive and energy that makes TOPRA the strong forward-looking professional organisation that we are today.

With that, I would like to wish everyone very happy holidays and every success in 2016!

SARAH ROBERTS, TOPRA PRESIDENTThe last few months have been busy for TOPRA with the Autumn Introductory Course, the Awards for Regulatory Excellence and the EMA Annual Outlook for 2016 taking place in quick succession!

Invest in your future

TOP TEAM FOR 2015It was announced at the Annual Symposium in Berlin that the TOPRA In Sweden Working Party were this year’s recipients of the ‘TOP Team’ Award.

Working Party Chair Margareth Jorvid said ‘on behalf of the Swedish team, I would like to thank the TOPRA Board and office for this surprise and honour’.

The team members were presented with their certificates by TOPRA Board member Lena Björk, MPA.

(L-R) Margareth Jorvid, Marina Stenlander, Vera Franzén, Ture Sjöblom, Charlotte Lewerth and Anna Mäkinen-Salmi. Missing from the team photo: Margareta Busk and Elisabeth Sundberg.

In this issue...

Yes – it’s that time of year again – lots of last minute deadlines to keep us busy, and plans to be made for 2016.

Much like with home life at this time of year, this month’s InTouch is in celebration mode, providing thoughts and ideas to consider for next year as well as the joy of a new baby, but also tinged with sadness for those we have lost.

We trust you all have a peaceful and happy time over the festive period and send you every good wish for 2016.

I wish you “Bliadhna Mhath Ùr” (pronounced blay in a va oor) which is Happy New Year in Gaelic. Ishbel MacDonaldRegulatory Consultant, MacDonald Regulatory Ltd,Co-Editor, InTouch

TOPRA InTouch Newsletter – December 2015

At the Annual Symposium this year TOPRA conducted research on attitudes to apprenticeships or vocational training in regulatory affairsFrom the results gained there was clear support for the concept, and we are therefore looking to coordinate the next stage of the process on behalf of our profession using the UK ‘Trailblazer’ programme as the model.

We would like to get a group together representing ten different companies in the human medicines and devices sector, to help shape a cross-industry ‘standard’ for regulatory apprentices. This group should include large companies and SMEs who do not need to have a commitment to taking on apprentices at this stage, but might like to think about it in the future.

The team would look at the knowledge, skills and behaviours that regulatory apprentices might be expected to gain and how these might be assessed. Setting the standards for entry levels and the final qualification achieved would also be part of the discussion.

This is a chance for you to help shape an important future development in our profession. If you would like to be considered for a place please email lynda@topra.org for more information.

DO YOU WANT TO BE PART OF SETTING A STANDARD?

Thank you Amber! The TOPRA office were pleased to welcome Amber Visch, a student from the Netherlands, to carry out her work experience in London. Amber helped to index Regulatory Rapporteur, contributing to the development of a better online keyword search for the journal.

“My name is Amber Visch and I am sixteen years old. I live in a town called Zutphen in the east of the Netherlands and I am currently doing pre-university bilingual secondary education, graduating in 2017.

As part of the fourth or fifth grade, my school gives me the great opportunity to go abroad and improve my English and communication skills as well as to learn independence.

This is why I came to TOPRA for my work experience – a short internship for one week. My experience both at TOPRA and in London really helped me with my English and I learned a lot about the way of life in London, how to be more independent and how to survive on my own, especially on the tube! I think this experience has been amazing for my personal growth and I would like to thank TOPRA for this opportunity.”

INVEST IN YOUR REGULATORY CAREERWith New Year’s resolutions just around the corner, now is the perfect time to think about studying regulatory affairs at an advanced level with the MSc Regulatory Affairs

As regulatory professionals we have a wide variety of career choices open to us. However, to take advantage of all these opportunities and to be successful we must keep up-to-date and continually refine our skills and knowledge. A great way to do this – and achieve a career-advancing qualification – is to undertake the MSc Regulatory Affairs (MSc RA).

This programme was set up by regulatory professionals for regulatory professionals – and it continues to be updated and delivered with your knowledge requirements and professional development needs paramount.

Proven track recordFor more than 25 years TOPRA has offered practising regulatory professionals the opportunity for in-depth study of the legal, scientific, strategic, managerial and practical aspects of international regulatory affairs in a part-time, modular course operating to postgraduate standard.

The MSc RA is validated by the University of Hertfordshire, an internationally renowned modern university with a strong portfolio in pharmaceutical-related subjects.

Join the elite in regulatory affairsSince its introduction in 1989, more than 300 students have

obtained a postgraduate qualification via this route – from PG certificate/diploma to the MScRA. This programme is recognised by industry and academia as being of an exceptionally high standard and of practical value in workplace situations. Alumni have invariably become exceptionally successful regulatory professionals.

Keep up-to-date and learn from the bestExperts from the competent authorities and industry give lectures and lead the case studies. You will have the opportunity to network with them outside of the lectures and discuss the latest developments.

The subjects and content of the modules are under constant review. As new legislation is drafted or implemented it is discussed within the appropriate module, often illustrated with case studies.

Make your New Year’s resolutionPlan ahead for 2016 and enrol now to broaden your regulatory affairs horizons and achieve regulatory excellence.

For more information visit www.topra.org/msc or contact Kay Wood, Postgraduate Administrator – kay@topra.org.

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA InTouch Newsletter – December 2015

The meeting was widely attended and the EMA provided a range of excellent speakers to address all of the most pressing topics of the moment in one excellent programme over two days.

The gathering was also an ideal way for the delegates to be sure they had the latest information on these key topics ‘straight from the horse’s mouth’, and also be given the chance to question and debate these issues with the community as a whole.

The highlight of the event was, as ever, the open roundtable where delegates could raise a wide range of questions to be answered by an impressive panel led by Tomas Salmonson.

AUTUMN INTRODUCTORY COURSE, 8–12 NOVEMBER, BERLIN

TIME TO REFLECT AND PLAN

TOPRA IN AUSTRIAOn 24 November a TOPRA In Austria networking and regulatory update meeting was held in Vienna

Speaker Vicky Jones of Sapienita Regulatory Services instructed delegates on the choice of procedure and an introduction to the case study.

The Autumn Introductory Course, held this year in Berlin, provided a great insight into the world of EU regulatory procedures and legislation

Intensive but well-structured, the course covered a wide range of regulatory topics – from the modules of the Common Technical Document (CTD), through to the different procedures on the registration path, variations, life cycle management, pharmacovigilance and medical devices.

Each day included a comprehensive case study to put into practice what was taught in the lectures, and also offered great opportunities for networking and creating new friendships.

The speakers were excellent – enthusiastic, engaging and happy to share their expert advice and practical considerations. Most of them were experts from industry, but the panel also featured independent consultants and representatives from regulatory agencies (BfArM, EMA and CMDh).

Overall, the course provided a worthwhile ground to build upon for an exciting career in regulatory affairs.

Lily Claret-Tournier, Covance, 2015 Autumn Introductory delegate

BUILDING A SOLID FOUNDATION

The Annual EMA Review of the Year and Outlook for 2016 took place at the EMA offices on 19–20 November

Speakers Elke Hofer-Litzlbauer (Baxalta) and Mariam Aslam (Parexel) investigated the latest issues in post-approval maintenance activities for 10 attendees.

The aim of TOPRA In Austria is to establish a network of local regulatory professionals with regular informal meetings to share experience and knowledge.

If you are interested to find out more about this group or TOPRA’s wide range of local networks please visit the community page at www.topra.org.

TOPRA In Austria members gathered for a local regulatory update and networking meeting in Vienna.

TOPRA InTouch Newsletter – December 2015

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA is the registered trademark of the The Organisation for Professionals in Regulatory Affairs Ltd, registered community trademark number 003182961. The TOPRA logo is covered by the Community Design Registration Numbers EU Des Reg no. 000055553-0001 and 0002.

In-House EditorRachel Cook

Co-Editors Greer Deal, Ishbel MacDonald and Graeme Ladds

PublisherJenine Willis

How to contact InTouchIf you would like to contribute to the newsletter, or find out about deadlines, please contact Rachel Cook (rachel@topra.org).Please address any articles and correspondence to: intouch@topra.org or submit your contribution via www.topra.org/intouchViews expressed in InTouch are those of the contributors and not necessarily those of the editors or TOPRA. While every effort is made to ensure information is accurate, conditions may change and readers are advised to consult current official texts and/or to seek appropriate professional advice before taking any regulatory action.© 2015 The Organisation for Professionals in Regulatory Affairs

TOPRA6th Floor 3 Harbour Exchange South Quay London E14 9GETel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 E-mail: topra@topra.org

InTouch is free to TOPRA members. Annual membership of TOPRA is £195. TOPRA members can read or download InTouch online at www.topra.org

Ms Marcella Coyne, QPPV, Pharmafile PV Services, Co. Meath, Ireland*

Dr Ludwig Baumann, Director RA, SynteractHCR, Munich, Germany*

Miss Amrit Jandu, Nottingham Trent University, UK (Student)

Miss Joanna McKinney, Data Processing Officer, Wockhardt, Denbigh, UK

Mrs Hollie Mullens, Senior RA Associate, Reckitt Benckiser, Reading, UK*

Ms Manuela Rodrigues, RA Associate, Xiros, Leeds, UK*

Ms Rachel Tinker, RA and Quality Assurance Manager, Sigma-Tau Rare Disease, Windsor, UK*

NEWTOPRAMEMBERSTOPRA welcomes the following new members who joined recently

*Registered Member

Ms Rachel Gibson, Regulatory Coordinator, East Yorkshire, UK

Ms Tiia Metiäinen, Manager RA, EFPIA, Brussels, Belgium

Ms Bandita Sarma, RA Officer, Disphar International, Baarn, Netherlands*

Ms Helen Delaney, Device Development Engineer, Mylan, Baldoyle, Ireland*

Mrs Deborah Cooper, VP Consulting, Genpact Pharmalink, High Wycombe, UK*

Miss Carmela Mastrandrea, Senior Consultant, Parexel International, London, UK

Miss Prabhjot Kaur, Regulatory Affairs Officer, Wockhardt, Wrexham, UK*

Mr Jubel Amin, Westminster University, UK (Student)

Ms Anita Stybaniewicz, Zaklady Farmaceutyczne Polpharma, Poland

Ms Karina Boszko, Zaklady Farmaceutyczne Polpharma, Poland

Mr Soufiane Dib, EU RI Manager, F.Hoffmann La-Roche, Basel, Switzerland*

Miss Ana-Maria Oltean, University of Medicine and Pharmacy, Blaj, Romania

Dr Karen Liu, Project Manager, Osmunda Medical Device Service Group, Berlin, Germany

Mr Ian Birch, Qualified Person, BECO Integrated

Services, Hertford, UK

Mr Ali Kais, London, UK (Student)

Ms Betsy Reddington, Director RA, Light Age, New Jersey, US

Mr Mitesh Panchal, RA Executive, Colonis Pharma, Tunbridge Wells, UK

Dr Ellen Veel, RA Officer, Disphar International, Diemen, Netherlands*

Mr Sailm Cali, London, UK (Student)

Ms Virginie Lefebvre-Dutilleul, Lawyer, EY Societé d’avocats, Courbevoie, France

Dr Josiane Raguzzoni, Research Scientist, UK (Student)

Tribute to Jenny Greenhorn

A surprise delegate!TOPRA has some exciting news to share this month following a new arrival during Module 7 of the MSc Regulatory Affairs! TOPRA member Kattia Lonsdale welcomed a baby boy weighing 7lb 9oz. We wish you every happiness for the future!

TOPRA’s Marketing and Communications Manager Erik Smit (L), and Regulatory Intelligence and Training Manager Christopher Bailey (R), both recently celebrated 10 years of working at TOPRA. Congratulations – here’s to the next 10!

10 YEARSAT TOPRA!

TOPRA Member Jenny Greenhorn sadly passed away on 21 November.

With over 20 years of experience in the pharmaceutical and medical device industries with SmithKline Beecham, Amersham Health and GE Healthcare, Jenny ran JJG Consultancy Ltd.

She worked extensively in regulatory affairs in both Europe and the US, and also in project management and business development roles.