KEEPING YOU THE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCH MAY 2013 In addition to the well-known introductory and other continuing professional development courses, TOPRA has a long history of successfully delivering two MSc courses. These Masters’ degrees are internationally recognised and are validated by partner institutions: the MSc in Regulatory Affairs was validated by the University of Wales; and the MSc in Medical Technology is validated by Cranfield University. At the beginning of my regulatory career, I completed the MSc in Regulatory Affairs and found it both inspiring and an invaluable foundation for my further development. It introduced every facet of regulatory affairs from a scientific, legal and commercial perspective. Personally and professionally, I can do nothing but advocate this Masters’ degree not only for our members but for their companies who will undoubtedly reap the benefits this course affords. In October 2011, the University of Wales announced it would no longer be validating any external institutions, including TOPRA. To ensure the long-term continuity of the TOPRA MSc, the TOPRA Board decided that this was an ideal opportunity to further develop the MSc by validating with another institution that would provide even greater commitment to high-quality regulatory education working with TOPRA. Exciting transition The TOPRA office undertook a great deal of activity to select a suitable validating institution. I am very pleased to announce that as a result of all this hard work, the TOPRA MSc in Regulatory Affairs will now be validated by the University of Hertfordshire (see Box). This university is one of the UK’s leading business-facing universities. TOPRA will soon Validating relationships A message from Patrizia Nestby, TOPRA President A pivotal role for TOPRA, as a professional membership organisation, is to provide high-quality education for its members, which is particularly important given the dynamic nature of the regulatory arena. release more information to existing and new students about this exciting transition. I would like to take this opportunity to thank the TOPRA staff for all their efforts to establish a relationship with such a highly respected validating institution, thereby ensuring the continuation of the MSc. I am convinced that this new relationship will offer the opportunity of a fresh start and will further evolve formal education provision in regulatory affairs. Announcement MSc in Regulatory Affairs is now validated by the University of Hertfordshire. In this issue... Healthcare regulatory affairs is often perceived as a niche specialty, but actually it is a vast subject. Therefore, as a regulatory professional it is vital to build up a network of colleagues and connections because, guess what, no one individual can know it all! It is often more important to know where to find the information, or who to contact, rather than expecting to have all the answers. It’s great to see that the MSc in Regulatory Affairs is to continue with the support of the University of Hertfordshire, which goes to show that regulatory affairs is a career choice. With the TOPRA Awards not so far away now, this is your chance to nominate one of your colleagues who you think has that special quality about them which should be recognised. It’s also everyone’s opportunity to raise the profile of our profession. Talking about that ‘special quality’, thank you, Virginia, for being a great co-editor (see back page) – let’s stay connected. Greer Deal, co-editor The University of Hertfordshire is one of the UK’s leading business-facing universities. It was awarded ‘Entrepreneurial University of the Year 2010’ by the Times Higher Education (THE) magazine. TOPRA’s successful modular Masters in Regulatory Affairs has been offered since 1989 and has seen more than 200 students graduate so far. The transfer to the University of Hertfordshire will ensure the long-term continuity of the TOPRA MSc to both new and existing students. Neil Fisher, TOPRA’s Director of Education and Training, said: ‘To be able to continue to offer our MSc with a high quality and well-respected institution means that this MSc qualification will continue to be regarded internationally as a relevant and high-quality award.’ The TOPRA MSc will be managed within Pharmacy, a department in the School of Life and Medical Sciences at the University of Hertfordshire. Benefits of partnering with this university include: ● Excellent library facilities ● Close links with leading pharmaceutical companies ● Other prestigious pharmaceutical courses are also validated, including an MSc in Pharmacovigilance.
TOPRA InTouch May 2013
Mar 27, 2016
TOPRA InTouch May 2013
Welcome message from author
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Transcript
K E E P I N G Y O U
T H E T O P R A N E W S L E T T E R ndash K E E P I N G M E M B E R S I N T O U C H MAY 2013
In addition to the well-known introductory and other continuing professional development courses TOPRA has a long history of successfully delivering two MSc courses
These Mastersrsquo degrees are internationally recognised and are validated by partner institutions the MSc in Regulatory Affairs was validated by the University of Wales and the MSc in Medical Technology is validated by Cranfield University
At the beginning of my regulatory career I completed the MSc in Regulatory Affairs and found it both inspiring and an invaluable foundation for my further development It introduced every facet of regulatory affairs from a scientific legal and commercial perspective Personally and professionally I can do nothing but advocate this Mastersrsquo degree not only for our members but for their companies who will undoubtedly reap the benefits this course affords
In October 2011 the University of Wales announced it would no longer be validating any external institutions including TOPRA To ensure the long-term continuity of the TOPRA MSc the TOPRA Board decided that this was an ideal opportunity to further develop the MSc by validating with another institution that would provide
even greater commitment to high-quality regulatory education working with TOPRA
Exciting transitionThe TOPRA office undertook a great deal of activity to select a suitable validating institution I am very pleased to announce that as a result of all this hard work the TOPRA MSc in Regulatory Affairs will now be validated by the University of Hertfordshire (see Box) This university is one of the UKrsquos leading business-facing universities TOPRA will soon
Validating relationshipsA message from Patrizia Nestby TOPRA President
A pivotal role for TOPRA as a professional membership organisation is to provide high-quality education for its members which is particularly important given the dynamic nature of the regulatory arena
release more information to existing and new students about this exciting transition
I would like to take this opportunity to thank the TOPRA staff for all their efforts to establish a relationship with such a highly respected validating institution thereby ensuring the continuation of the MSc I am convinced that this new relationship will offer the opportunity of a fresh start and will further evolve formal education provision in regulatory affairs
AnnouncementMSc in Regulatory Affairs is now validated by the University of Hertfordshire
In this issueHealthcare regulatory affairs is often perceived as a niche specialty but actually it is a vast subject Therefore as a regulatory professional it is vital to build up a network of colleagues and connections because guess what no one individual can know it all It is often more important to know where to find the information or who to contact rather than expecting to have all the answers Itrsquos great to see that the MSc in Regulatory Affairs is to continue with the support of the University of Hertfordshire which goes to show that regulatory affairs is a career choice With the TOPRA Awards not so far away now this is your chance to nominate one of your colleagues who you think has that special quality about them which should be recognised Itrsquos also everyonersquos opportunity to raise the profile of our profession Talking about that lsquospecial qualityrsquo thank you Virginia for being a great co-editor (see back page) ndash letrsquos stay connectedGreer Deal co-editor
The University of Hertfordshire is one of the UKrsquos leading business-facing universities It was awarded lsquoEntrepreneurial University of the Year 2010rsquo by the Times Higher Education (THE) magazine
TOPRArsquos successful modular Masters in Regulatory Affairs has been offered since 1989 and has seen more than 200 students graduate so far The transfer to the University of Hertfordshire will ensure the long-term continuity of the TOPRA MSc to both new and existing students
Neil Fisher TOPRArsquos Director of Education and Training said lsquoTo be able to continue to offer our MSc with a high quality and well-respected institution means that this MSc qualification will continue to be regarded internationally as a relevant and high-quality awardrsquo
The TOPRA MSc will be managed within Pharmacy a department in the School of Life and Medical Sciences at the University of Hertfordshire Benefits of partnering with this university include Excellent library facilities Close links with leading pharmaceutical companies Other prestigious pharmaceutical courses are also
validated including an MSc in Pharmacovigilance
K E E P I N G Y O U
Patients seek EmpowermentEmpower was founded by a patient with motor neurone disease (MND) and is aiming to introduce a protocol into the UK to allow patients with very rare terminal diseases to have early access to new medicines through modification of their legal remedies against the developer and clinicians concerned
Lynda Wight attended a summit at the UK Parliament to hear a number of interested parties debate the issues MPs industry representatives patients and clinical investigators highlighted the tensions between the current UK infrastructure the rapid revolution in scientific advances and the current regulatory requirements that mean that innovative new treatments for such diseases take too long and are too expensive to bring to market ndash and cannot always be made available to patients when they are licensed
The importance of collaboration between innovators healthcare providers and patient charities was highlighted This fascinating debate was made more poignant by the video of the founder of Empower Les Halpin for whom any changes will come too late but who is devoting all his energies to trying to change the status quo for future patients in his position
For more information go to wwwaccesstomedicinecouk
MSc Module focuses on regulatory requirements in clinical researchModule 5 of the TOPRA MSc course lsquoRegulatory Control of Clinical Operationsrsquo was held in Prague Czech Republic on 16ndash18 April This module focuses on the practical regulatory aspects of global clinical research providing effective advice on the regulatory issues likely to arise during clinical programmes
The course was well attended with delegates from Czech Republic Germany France the Netherlands Portugal Ireland Denmark and the UK from companies including Merial H Lundbeck K-Pharma Gruenethal Teva Boehringer Ingelheim and Bonifar We welcomed four new students to the course from Tillomed Laboratories DSTL K-Pharma Consulting and Teva Several non-MSc delegates also joined the module
Paul McInulty the module leader and his team Angela Stokes and Eva Kopecna produced an exciting programme Speakers included Dr Alexandra Hoebel from AGES Austria and Elaine Godfrey from the UKrsquos MHRA who presented an agency perspective on submissions They were joined by speakers from the Czech Republic
Our next MSc Module 6 on lsquoRegulatory Strategy The Market Placersquo will take place at DeVere The Grand Hotel Brighton UK from 11ndash13 June 2013 Please go to wwwtopraorgevents for further information and a booking form
Veterinary Symposium Working Party planning well underwayA key part of the TOPRA Annual Symposia is the Veterinary Symposium which will run from 17-18 October in Lisbon Portugal this year
The programme is now taking shape On 9 April Ray Harding (chair of the working party) and Christopher Bailey of TOPRA visited the Veterinary agency DGAV (Direcccedilatildeo-Geral de Alimentaccedilatildeo e Veterinaacuteria) with a local member of the working party Joatildeo Lourenco of Zoetis Portugal
At the DGAV they met with Helena Ponte (veterinary medicines and plant protection department director) Maria Azevedo Mendes (veterinary medicines chief unit) and Inecircs Dias (scientific staff)
A very cordial discussion took place and Helena welcomed the opportunity to work with TOPRA on the 2013 Veterinary Symposium The meeting ended with a visit to the rooftop of DGAV (pictured) to admire the panoramic views of the castle and waterfront
Go to wwwtoprasymposiumorg for all the latest updates
Students from last monthrsquos Spring Introductory Course get to work on the practical case studies and sessions (pictured left and right) and to socialise later (middle) The Autumn Introductory Course will take place on 3ndash7 November in Berlin Germany For more information go to wwwtopraorgintroductorycourse
Getting to know you ndash Introductory Course students mix learning and networking
A U G U S T 2 0 0 9w w w t o p r a o r g i n t o u c h
AWARDS TIMELINESRegister your interest in entering the Awards ndash NOW
Closing date ndash Friday 20 June
Shortlist announced ndash mid-September
Awards ceremony ndash 27 November The TOPRA Regulatory Affairs Awards 2013 will be held in London UK Watch out for news updates on the event at wwwregulatory affairsawardsorg
TOPRA Awards 2013Would you like to be an AmbassadorWe are looking for volunteers to help the Working Party by being Ambassadors to spread the word about the Awards in the profession Our aim is to ensure that dynamic committed professionals working in the sector are recognised for the important contributions they have made in their respective areas
To achieve this goal our Ambassadors will reach out to colleagues or clients in their professional networks to champion awareness of the Awards categories and their timelines along with sourcing and encouraging potential nominees
Ambassadors do not have to focus on one category you can champion all or any of the categories you can identify with This is an exciting and rewarding role which will enable you to become personally involved in recognising the achievements made by your colleagues at all levels of the industry
The Awards website (wwwregulatoryaffairsawardsorg) contains details of our prestigious judging panel the categories of Awards and links to the nomination forms If you would like to get involved in helping us promote our profession and motivate the very best people in it by encouraging more nominations to this yearrsquos event (or by making one yourself) please contact Rachel Cook (racheltopraorg) for further information
For more information or to nominate visit wwwregulatoryaffairsawardsorg
Enter
NOW
Inspiration
For individuals who inspire their fellow professionals in their work or encourage them to take their regulatory career further or to acknowledge excellence in leadership
Championed by Craig McCarthy CAMPHARM
Horizon
For individuals with less than three yearsrsquo experience in the regulatory profession who have shown exceptional promise in the field
Championed by Dianne Lee DLRC
Communication
This category recognises the importance of clear and effective communication in regulatory affairs whether it be professional to professional or for wider publication
Championed by Monique Garrett Prism Works
Education
For designing developing and delivering regulatory education ndash from formal qualifications to in-house training
Championed by John Deavin Deavin Associates
Innovation
Recognises those who have identified inefficient processes or other regulatory issues and have resolved them in an innovative fashion
Championed by Gerald Thompson Boots
Support
Recognising the role of support organisations in delivering effective consultancy or other business solutions to regulatory teams and companies
Championed by Elke Hofer-Litzlbauer Baxter
Life Time Achievement
Acknowledging an individualrsquos lifetime of achievement and contribution to developing regulatory affairs
Championed by Alan Hunter past president TOPRA
Championing the Awards This yearrsquos nomination process is open and the Awards Working Party invites you to enter your colleagues in the relevant categories Members of the Awards Working Party have initiated the process by each championing one particular Award as follows
Donrsquot forget to follow us on Twitter ndash TOPRANEWS TOPRAAwards2013
samarindRMS SUPPORTER OF THE INNOVATION CATEGORY
THE TOPRA NE WSLE T TER ndash KEEPING MEMBERS IN TOUCH MAY 2013
wwwtopraorgintouch
K E E P I N G Y O U
MAY 2013
InTouch Editors Jenine Willis Greer Deal and Virginia Guellal
How to contact InTouchInTouch welcomes contributions from TOPRA members
If you would like to contribute to the newsletter or find out about deadlines please contact Jenine Willis (jeninetopraorg)
Please address any articles and correspondence to intouchtopraorg or submit your contribution via wwwtopraorgintouch
Views 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 andor to seek appropriate professional advice before taking any regulatory action
copy 2013 The Organisation for Professionals in Regulatory Affairs
TOPRABellerive House 3 Muirfield Crescent London E14 9SZ
Tel +44 (0) 20 7510 2560 Fax +44 (0) 20 7537 2003 Email topratopraorg
InTouch is free to TOPRA members Annual membership of TOPRA is euro225 TOPRA members can read or download InTouch online at wwwtopraorg
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
NEWTOPRAMEMBERSDr Annabella Amatulli Regulatory Affairs Specialist Italy
Ms Jane Bainbridge New Jersey US
Dr Leslie Bannon Regulatory Consultant Switzerland
Ms Segren Bernard Senior Consultant Swindon UK
Ms Marissa Campbell Regulatory Affairs Officer Martindale Pharmaceuticals Romford UK
Mr Carl Brooker Regulatory Project Manager DLRC Hertfordshire UK
Dr Catherine Davies Regulatory Associate Reckitt Benckiser Healthcare Hull UK
Mrs Claire Bailey Regulatory Affairs Team Manager AstraZeneca UK Luton UK
Mrs Claire Roche Global CMC Manager Pfizer Co Dublin Ireland
Dr Costantino Congiatu Regulatory Affairs Specialist PPD Cambridge UK
Mrs Jesantha Coy Regulatory Affairs Manager Allergan Marlow UK
Ms Anna Cruz Regulatory Affairs Senior Associate Alliance Pharmaceuticals Chippenham UK
Mr Michael Edwards Brackley UK
Miss Gina Prat Regulatory Affairs Affiliate Amgen Uxbridge UK
Dr John Hares Regulatory Affairs Associate Assistant Alliance Pharmaceuticals Chippenham UK
Mrs Hilde Bastaerts Associate Director CMC Dossier Development Janssen RampD Beerse Belgium
Ms Inge Schorpion Scientist Beerse Belgium
Mrs Karen Hill Regulatory Affairs Manager Vascutek Renfrewshire UK
Mrs Laura Kanter Regulatory Affairs Officer HRA Pharma France
Miss Nicole Liska Cambridge UK (Student)
Mrs Annie Martin Cambridge UK
Ms Martina Foster Senior Regulatory Affairs Consultant Real Regulatory Dublin Ireland
Miss Maria-Cristina Martin-Paniza Deal UK
Miss Sarah Masoudi Chiswick UK (Student)
Miss Erika Mercer Surbiton UK
Miss Rosaleen Moylan QA and RA Engineer and QP ArcRoyal Kells Ireland
Miss Malwina Niemczyk Cambridge UK (Student)
Dr Nikolaos Charlaftis Research Associate Imperial College London UK
Mr Paul Johnson Consultant Clinscisive Services Auckland New Zealand
Mr Rasan Vaid Regulatory Affairs Project Manager GlaxoSmithKline UK Uxbridge UK
Miss Rebecca Evans Regulatory Affairs Officer Wockhardt UK Wrexham UK
Mr Christopher Sharpe Chesham UK
Dr Michael Titus Maryland US
Miss Dunja Vukic Pharmacovigilance Associate PrimeVigilance Zagreb Croatia
Dr Jennifer Yen Cambridge UK
Ms Ana Zaccaro Regulatory Affairs Manager Takeda Global R amp D Centre (Europe) London UK
Registered Member
TOPRA welcomes the following new members who joined recently
Founder member receives certificateExecutive Director Lynda Wight and Alan Hunter Chair of the lsquoSTARrsquo Panelndash which ensures that success and achievement is recognised by TOPRA ndash visited the home of R Keith Greenwood to present him with his Honorary Life Membership certificate
Keith was a founder member of this organisation back in the 1970s and served as Chairman and leader of our Education efforts when some of our most important training initiatives were launched
He established the financial philosophy for the organisation that has ensured its continued stability and opportunity for growth He will be remembered with affection for his incisive and witty contributions to our conferences both from the platform and audience
In the wider world Keith was a pioneer in the emerging CRO industry and founded the Regulatory Affairs Journal Keith was awarded Honorary Life Membership some years ago but a bout of ill health now resolved prevented him from attending a presentation ceremony
Keith sends good wishes to his many friends in TOPRA and would be delighted to hear from them Contact the office for more information
Thank you VirginiaAfter several years as co-editor of InTouch Virginia Guellal is hanging up her shoes Her co-editor Greer Deal says lsquoVirginia has been such a pleasure to work with always professional and great fun I shall miss her emails sent in the early hours of the morning and her never-ending enthusiasm for her work and for our profession Thank you Virginia for your help and support lsquoIf you would like to join the InTouch editiorial team please email jeninetopraorg
Virginia with her daughter at a charity run last year
K E E P I N G Y O U
Patients seek EmpowermentEmpower was founded by a patient with motor neurone disease (MND) and is aiming to introduce a protocol into the UK to allow patients with very rare terminal diseases to have early access to new medicines through modification of their legal remedies against the developer and clinicians concerned
Lynda Wight attended a summit at the UK Parliament to hear a number of interested parties debate the issues MPs industry representatives patients and clinical investigators highlighted the tensions between the current UK infrastructure the rapid revolution in scientific advances and the current regulatory requirements that mean that innovative new treatments for such diseases take too long and are too expensive to bring to market ndash and cannot always be made available to patients when they are licensed
The importance of collaboration between innovators healthcare providers and patient charities was highlighted This fascinating debate was made more poignant by the video of the founder of Empower Les Halpin for whom any changes will come too late but who is devoting all his energies to trying to change the status quo for future patients in his position
For more information go to wwwaccesstomedicinecouk
MSc Module focuses on regulatory requirements in clinical researchModule 5 of the TOPRA MSc course lsquoRegulatory Control of Clinical Operationsrsquo was held in Prague Czech Republic on 16ndash18 April This module focuses on the practical regulatory aspects of global clinical research providing effective advice on the regulatory issues likely to arise during clinical programmes
The course was well attended with delegates from Czech Republic Germany France the Netherlands Portugal Ireland Denmark and the UK from companies including Merial H Lundbeck K-Pharma Gruenethal Teva Boehringer Ingelheim and Bonifar We welcomed four new students to the course from Tillomed Laboratories DSTL K-Pharma Consulting and Teva Several non-MSc delegates also joined the module
Paul McInulty the module leader and his team Angela Stokes and Eva Kopecna produced an exciting programme Speakers included Dr Alexandra Hoebel from AGES Austria and Elaine Godfrey from the UKrsquos MHRA who presented an agency perspective on submissions They were joined by speakers from the Czech Republic
Our next MSc Module 6 on lsquoRegulatory Strategy The Market Placersquo will take place at DeVere The Grand Hotel Brighton UK from 11ndash13 June 2013 Please go to wwwtopraorgevents for further information and a booking form
Veterinary Symposium Working Party planning well underwayA key part of the TOPRA Annual Symposia is the Veterinary Symposium which will run from 17-18 October in Lisbon Portugal this year
The programme is now taking shape On 9 April Ray Harding (chair of the working party) and Christopher Bailey of TOPRA visited the Veterinary agency DGAV (Direcccedilatildeo-Geral de Alimentaccedilatildeo e Veterinaacuteria) with a local member of the working party Joatildeo Lourenco of Zoetis Portugal
At the DGAV they met with Helena Ponte (veterinary medicines and plant protection department director) Maria Azevedo Mendes (veterinary medicines chief unit) and Inecircs Dias (scientific staff)
A very cordial discussion took place and Helena welcomed the opportunity to work with TOPRA on the 2013 Veterinary Symposium The meeting ended with a visit to the rooftop of DGAV (pictured) to admire the panoramic views of the castle and waterfront
Go to wwwtoprasymposiumorg for all the latest updates
Students from last monthrsquos Spring Introductory Course get to work on the practical case studies and sessions (pictured left and right) and to socialise later (middle) The Autumn Introductory Course will take place on 3ndash7 November in Berlin Germany For more information go to wwwtopraorgintroductorycourse
Getting to know you ndash Introductory Course students mix learning and networking
A U G U S T 2 0 0 9w w w t o p r a o r g i n t o u c h
AWARDS TIMELINESRegister your interest in entering the Awards ndash NOW
Closing date ndash Friday 20 June
Shortlist announced ndash mid-September
Awards ceremony ndash 27 November The TOPRA Regulatory Affairs Awards 2013 will be held in London UK Watch out for news updates on the event at wwwregulatory affairsawardsorg
TOPRA Awards 2013Would you like to be an AmbassadorWe are looking for volunteers to help the Working Party by being Ambassadors to spread the word about the Awards in the profession Our aim is to ensure that dynamic committed professionals working in the sector are recognised for the important contributions they have made in their respective areas
To achieve this goal our Ambassadors will reach out to colleagues or clients in their professional networks to champion awareness of the Awards categories and their timelines along with sourcing and encouraging potential nominees
Ambassadors do not have to focus on one category you can champion all or any of the categories you can identify with This is an exciting and rewarding role which will enable you to become personally involved in recognising the achievements made by your colleagues at all levels of the industry
The Awards website (wwwregulatoryaffairsawardsorg) contains details of our prestigious judging panel the categories of Awards and links to the nomination forms If you would like to get involved in helping us promote our profession and motivate the very best people in it by encouraging more nominations to this yearrsquos event (or by making one yourself) please contact Rachel Cook (racheltopraorg) for further information
For more information or to nominate visit wwwregulatoryaffairsawardsorg
Enter
NOW
Inspiration
For individuals who inspire their fellow professionals in their work or encourage them to take their regulatory career further or to acknowledge excellence in leadership
Championed by Craig McCarthy CAMPHARM
Horizon
For individuals with less than three yearsrsquo experience in the regulatory profession who have shown exceptional promise in the field
Championed by Dianne Lee DLRC
Communication
This category recognises the importance of clear and effective communication in regulatory affairs whether it be professional to professional or for wider publication
Championed by Monique Garrett Prism Works
Education
For designing developing and delivering regulatory education ndash from formal qualifications to in-house training
Championed by John Deavin Deavin Associates
Innovation
Recognises those who have identified inefficient processes or other regulatory issues and have resolved them in an innovative fashion
Championed by Gerald Thompson Boots
Support
Recognising the role of support organisations in delivering effective consultancy or other business solutions to regulatory teams and companies
Championed by Elke Hofer-Litzlbauer Baxter
Life Time Achievement
Acknowledging an individualrsquos lifetime of achievement and contribution to developing regulatory affairs
Championed by Alan Hunter past president TOPRA
Championing the Awards This yearrsquos nomination process is open and the Awards Working Party invites you to enter your colleagues in the relevant categories Members of the Awards Working Party have initiated the process by each championing one particular Award as follows
Donrsquot forget to follow us on Twitter ndash TOPRANEWS TOPRAAwards2013
samarindRMS SUPPORTER OF THE INNOVATION CATEGORY
THE TOPRA NE WSLE T TER ndash KEEPING MEMBERS IN TOUCH MAY 2013
wwwtopraorgintouch
K E E P I N G Y O U
MAY 2013
InTouch Editors Jenine Willis Greer Deal and Virginia Guellal
How to contact InTouchInTouch welcomes contributions from TOPRA members
If you would like to contribute to the newsletter or find out about deadlines please contact Jenine Willis (jeninetopraorg)
Please address any articles and correspondence to intouchtopraorg or submit your contribution via wwwtopraorgintouch
Views 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 andor to seek appropriate professional advice before taking any regulatory action
copy 2013 The Organisation for Professionals in Regulatory Affairs
TOPRABellerive House 3 Muirfield Crescent London E14 9SZ
Tel +44 (0) 20 7510 2560 Fax +44 (0) 20 7537 2003 Email topratopraorg
InTouch is free to TOPRA members Annual membership of TOPRA is euro225 TOPRA members can read or download InTouch online at wwwtopraorg
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
NEWTOPRAMEMBERSDr Annabella Amatulli Regulatory Affairs Specialist Italy
Ms Jane Bainbridge New Jersey US
Dr Leslie Bannon Regulatory Consultant Switzerland
Ms Segren Bernard Senior Consultant Swindon UK
Ms Marissa Campbell Regulatory Affairs Officer Martindale Pharmaceuticals Romford UK
Mr Carl Brooker Regulatory Project Manager DLRC Hertfordshire UK
Dr Catherine Davies Regulatory Associate Reckitt Benckiser Healthcare Hull UK
Mrs Claire Bailey Regulatory Affairs Team Manager AstraZeneca UK Luton UK
Mrs Claire Roche Global CMC Manager Pfizer Co Dublin Ireland
Dr Costantino Congiatu Regulatory Affairs Specialist PPD Cambridge UK
Mrs Jesantha Coy Regulatory Affairs Manager Allergan Marlow UK
Ms Anna Cruz Regulatory Affairs Senior Associate Alliance Pharmaceuticals Chippenham UK
Mr Michael Edwards Brackley UK
Miss Gina Prat Regulatory Affairs Affiliate Amgen Uxbridge UK
Dr John Hares Regulatory Affairs Associate Assistant Alliance Pharmaceuticals Chippenham UK
Mrs Hilde Bastaerts Associate Director CMC Dossier Development Janssen RampD Beerse Belgium
Ms Inge Schorpion Scientist Beerse Belgium
Mrs Karen Hill Regulatory Affairs Manager Vascutek Renfrewshire UK
Mrs Laura Kanter Regulatory Affairs Officer HRA Pharma France
Miss Nicole Liska Cambridge UK (Student)
Mrs Annie Martin Cambridge UK
Ms Martina Foster Senior Regulatory Affairs Consultant Real Regulatory Dublin Ireland
Miss Maria-Cristina Martin-Paniza Deal UK
Miss Sarah Masoudi Chiswick UK (Student)
Miss Erika Mercer Surbiton UK
Miss Rosaleen Moylan QA and RA Engineer and QP ArcRoyal Kells Ireland
Miss Malwina Niemczyk Cambridge UK (Student)
Dr Nikolaos Charlaftis Research Associate Imperial College London UK
Mr Paul Johnson Consultant Clinscisive Services Auckland New Zealand
Mr Rasan Vaid Regulatory Affairs Project Manager GlaxoSmithKline UK Uxbridge UK
Miss Rebecca Evans Regulatory Affairs Officer Wockhardt UK Wrexham UK
Mr Christopher Sharpe Chesham UK
Dr Michael Titus Maryland US
Miss Dunja Vukic Pharmacovigilance Associate PrimeVigilance Zagreb Croatia
Dr Jennifer Yen Cambridge UK
Ms Ana Zaccaro Regulatory Affairs Manager Takeda Global R amp D Centre (Europe) London UK
Registered Member
TOPRA welcomes the following new members who joined recently
Founder member receives certificateExecutive Director Lynda Wight and Alan Hunter Chair of the lsquoSTARrsquo Panelndash which ensures that success and achievement is recognised by TOPRA ndash visited the home of R Keith Greenwood to present him with his Honorary Life Membership certificate
Keith was a founder member of this organisation back in the 1970s and served as Chairman and leader of our Education efforts when some of our most important training initiatives were launched
He established the financial philosophy for the organisation that has ensured its continued stability and opportunity for growth He will be remembered with affection for his incisive and witty contributions to our conferences both from the platform and audience
In the wider world Keith was a pioneer in the emerging CRO industry and founded the Regulatory Affairs Journal Keith was awarded Honorary Life Membership some years ago but a bout of ill health now resolved prevented him from attending a presentation ceremony
Keith sends good wishes to his many friends in TOPRA and would be delighted to hear from them Contact the office for more information
Thank you VirginiaAfter several years as co-editor of InTouch Virginia Guellal is hanging up her shoes Her co-editor Greer Deal says lsquoVirginia has been such a pleasure to work with always professional and great fun I shall miss her emails sent in the early hours of the morning and her never-ending enthusiasm for her work and for our profession Thank you Virginia for your help and support lsquoIf you would like to join the InTouch editiorial team please email jeninetopraorg
Virginia with her daughter at a charity run last year
A U G U S T 2 0 0 9w w w t o p r a o r g i n t o u c h
AWARDS TIMELINESRegister your interest in entering the Awards ndash NOW
Closing date ndash Friday 20 June
Shortlist announced ndash mid-September
Awards ceremony ndash 27 November The TOPRA Regulatory Affairs Awards 2013 will be held in London UK Watch out for news updates on the event at wwwregulatory affairsawardsorg
TOPRA Awards 2013Would you like to be an AmbassadorWe are looking for volunteers to help the Working Party by being Ambassadors to spread the word about the Awards in the profession Our aim is to ensure that dynamic committed professionals working in the sector are recognised for the important contributions they have made in their respective areas
To achieve this goal our Ambassadors will reach out to colleagues or clients in their professional networks to champion awareness of the Awards categories and their timelines along with sourcing and encouraging potential nominees
Ambassadors do not have to focus on one category you can champion all or any of the categories you can identify with This is an exciting and rewarding role which will enable you to become personally involved in recognising the achievements made by your colleagues at all levels of the industry
The Awards website (wwwregulatoryaffairsawardsorg) contains details of our prestigious judging panel the categories of Awards and links to the nomination forms If you would like to get involved in helping us promote our profession and motivate the very best people in it by encouraging more nominations to this yearrsquos event (or by making one yourself) please contact Rachel Cook (racheltopraorg) for further information
For more information or to nominate visit wwwregulatoryaffairsawardsorg
Enter
NOW
Inspiration
For individuals who inspire their fellow professionals in their work or encourage them to take their regulatory career further or to acknowledge excellence in leadership
Championed by Craig McCarthy CAMPHARM
Horizon
For individuals with less than three yearsrsquo experience in the regulatory profession who have shown exceptional promise in the field
Championed by Dianne Lee DLRC
Communication
This category recognises the importance of clear and effective communication in regulatory affairs whether it be professional to professional or for wider publication
Championed by Monique Garrett Prism Works
Education
For designing developing and delivering regulatory education ndash from formal qualifications to in-house training
Championed by John Deavin Deavin Associates
Innovation
Recognises those who have identified inefficient processes or other regulatory issues and have resolved them in an innovative fashion
Championed by Gerald Thompson Boots
Support
Recognising the role of support organisations in delivering effective consultancy or other business solutions to regulatory teams and companies
Championed by Elke Hofer-Litzlbauer Baxter
Life Time Achievement
Acknowledging an individualrsquos lifetime of achievement and contribution to developing regulatory affairs
Championed by Alan Hunter past president TOPRA
Championing the Awards This yearrsquos nomination process is open and the Awards Working Party invites you to enter your colleagues in the relevant categories Members of the Awards Working Party have initiated the process by each championing one particular Award as follows
Donrsquot forget to follow us on Twitter ndash TOPRANEWS TOPRAAwards2013
samarindRMS SUPPORTER OF THE INNOVATION CATEGORY
THE TOPRA NE WSLE T TER ndash KEEPING MEMBERS IN TOUCH MAY 2013
wwwtopraorgintouch
K E E P I N G Y O U
MAY 2013
InTouch Editors Jenine Willis Greer Deal and Virginia Guellal
How to contact InTouchInTouch welcomes contributions from TOPRA members
If you would like to contribute to the newsletter or find out about deadlines please contact Jenine Willis (jeninetopraorg)
Please address any articles and correspondence to intouchtopraorg or submit your contribution via wwwtopraorgintouch
Views 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 andor to seek appropriate professional advice before taking any regulatory action
copy 2013 The Organisation for Professionals in Regulatory Affairs
TOPRABellerive House 3 Muirfield Crescent London E14 9SZ
Tel +44 (0) 20 7510 2560 Fax +44 (0) 20 7537 2003 Email topratopraorg
InTouch is free to TOPRA members Annual membership of TOPRA is euro225 TOPRA members can read or download InTouch online at wwwtopraorg
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
NEWTOPRAMEMBERSDr Annabella Amatulli Regulatory Affairs Specialist Italy
Ms Jane Bainbridge New Jersey US
Dr Leslie Bannon Regulatory Consultant Switzerland
Ms Segren Bernard Senior Consultant Swindon UK
Ms Marissa Campbell Regulatory Affairs Officer Martindale Pharmaceuticals Romford UK
Mr Carl Brooker Regulatory Project Manager DLRC Hertfordshire UK
Dr Catherine Davies Regulatory Associate Reckitt Benckiser Healthcare Hull UK
Mrs Claire Bailey Regulatory Affairs Team Manager AstraZeneca UK Luton UK
Mrs Claire Roche Global CMC Manager Pfizer Co Dublin Ireland
Dr Costantino Congiatu Regulatory Affairs Specialist PPD Cambridge UK
Mrs Jesantha Coy Regulatory Affairs Manager Allergan Marlow UK
Ms Anna Cruz Regulatory Affairs Senior Associate Alliance Pharmaceuticals Chippenham UK
Mr Michael Edwards Brackley UK
Miss Gina Prat Regulatory Affairs Affiliate Amgen Uxbridge UK
Dr John Hares Regulatory Affairs Associate Assistant Alliance Pharmaceuticals Chippenham UK
Mrs Hilde Bastaerts Associate Director CMC Dossier Development Janssen RampD Beerse Belgium
Ms Inge Schorpion Scientist Beerse Belgium
Mrs Karen Hill Regulatory Affairs Manager Vascutek Renfrewshire UK
Mrs Laura Kanter Regulatory Affairs Officer HRA Pharma France
Miss Nicole Liska Cambridge UK (Student)
Mrs Annie Martin Cambridge UK
Ms Martina Foster Senior Regulatory Affairs Consultant Real Regulatory Dublin Ireland
Miss Maria-Cristina Martin-Paniza Deal UK
Miss Sarah Masoudi Chiswick UK (Student)
Miss Erika Mercer Surbiton UK
Miss Rosaleen Moylan QA and RA Engineer and QP ArcRoyal Kells Ireland
Miss Malwina Niemczyk Cambridge UK (Student)
Dr Nikolaos Charlaftis Research Associate Imperial College London UK
Mr Paul Johnson Consultant Clinscisive Services Auckland New Zealand
Mr Rasan Vaid Regulatory Affairs Project Manager GlaxoSmithKline UK Uxbridge UK
Miss Rebecca Evans Regulatory Affairs Officer Wockhardt UK Wrexham UK
Mr Christopher Sharpe Chesham UK
Dr Michael Titus Maryland US
Miss Dunja Vukic Pharmacovigilance Associate PrimeVigilance Zagreb Croatia
Dr Jennifer Yen Cambridge UK
Ms Ana Zaccaro Regulatory Affairs Manager Takeda Global R amp D Centre (Europe) London UK
Registered Member
TOPRA welcomes the following new members who joined recently
Founder member receives certificateExecutive Director Lynda Wight and Alan Hunter Chair of the lsquoSTARrsquo Panelndash which ensures that success and achievement is recognised by TOPRA ndash visited the home of R Keith Greenwood to present him with his Honorary Life Membership certificate
Keith was a founder member of this organisation back in the 1970s and served as Chairman and leader of our Education efforts when some of our most important training initiatives were launched
He established the financial philosophy for the organisation that has ensured its continued stability and opportunity for growth He will be remembered with affection for his incisive and witty contributions to our conferences both from the platform and audience
In the wider world Keith was a pioneer in the emerging CRO industry and founded the Regulatory Affairs Journal Keith was awarded Honorary Life Membership some years ago but a bout of ill health now resolved prevented him from attending a presentation ceremony
Keith sends good wishes to his many friends in TOPRA and would be delighted to hear from them Contact the office for more information
Thank you VirginiaAfter several years as co-editor of InTouch Virginia Guellal is hanging up her shoes Her co-editor Greer Deal says lsquoVirginia has been such a pleasure to work with always professional and great fun I shall miss her emails sent in the early hours of the morning and her never-ending enthusiasm for her work and for our profession Thank you Virginia for your help and support lsquoIf you would like to join the InTouch editiorial team please email jeninetopraorg
Virginia with her daughter at a charity run last year
wwwtopraorgintouch
K E E P I N G Y O U
MAY 2013
InTouch Editors Jenine Willis Greer Deal and Virginia Guellal
How to contact InTouchInTouch welcomes contributions from TOPRA members
If you would like to contribute to the newsletter or find out about deadlines please contact Jenine Willis (jeninetopraorg)
Please address any articles and correspondence to intouchtopraorg or submit your contribution via wwwtopraorgintouch
Views 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 andor to seek appropriate professional advice before taking any regulatory action
copy 2013 The Organisation for Professionals in Regulatory Affairs
TOPRABellerive House 3 Muirfield Crescent London E14 9SZ
Tel +44 (0) 20 7510 2560 Fax +44 (0) 20 7537 2003 Email topratopraorg
InTouch is free to TOPRA members Annual membership of TOPRA is euro225 TOPRA members can read or download InTouch online at wwwtopraorg
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
NEWTOPRAMEMBERSDr Annabella Amatulli Regulatory Affairs Specialist Italy
Ms Jane Bainbridge New Jersey US
Dr Leslie Bannon Regulatory Consultant Switzerland
Ms Segren Bernard Senior Consultant Swindon UK
Ms Marissa Campbell Regulatory Affairs Officer Martindale Pharmaceuticals Romford UK
Mr Carl Brooker Regulatory Project Manager DLRC Hertfordshire UK
Dr Catherine Davies Regulatory Associate Reckitt Benckiser Healthcare Hull UK
Mrs Claire Bailey Regulatory Affairs Team Manager AstraZeneca UK Luton UK
Mrs Claire Roche Global CMC Manager Pfizer Co Dublin Ireland
Dr Costantino Congiatu Regulatory Affairs Specialist PPD Cambridge UK
Mrs Jesantha Coy Regulatory Affairs Manager Allergan Marlow UK
Ms Anna Cruz Regulatory Affairs Senior Associate Alliance Pharmaceuticals Chippenham UK
Mr Michael Edwards Brackley UK
Miss Gina Prat Regulatory Affairs Affiliate Amgen Uxbridge UK
Dr John Hares Regulatory Affairs Associate Assistant Alliance Pharmaceuticals Chippenham UK
Mrs Hilde Bastaerts Associate Director CMC Dossier Development Janssen RampD Beerse Belgium
Ms Inge Schorpion Scientist Beerse Belgium
Mrs Karen Hill Regulatory Affairs Manager Vascutek Renfrewshire UK
Mrs Laura Kanter Regulatory Affairs Officer HRA Pharma France
Miss Nicole Liska Cambridge UK (Student)
Mrs Annie Martin Cambridge UK
Ms Martina Foster Senior Regulatory Affairs Consultant Real Regulatory Dublin Ireland
Miss Maria-Cristina Martin-Paniza Deal UK
Miss Sarah Masoudi Chiswick UK (Student)
Miss Erika Mercer Surbiton UK
Miss Rosaleen Moylan QA and RA Engineer and QP ArcRoyal Kells Ireland
Miss Malwina Niemczyk Cambridge UK (Student)
Dr Nikolaos Charlaftis Research Associate Imperial College London UK
Mr Paul Johnson Consultant Clinscisive Services Auckland New Zealand
Mr Rasan Vaid Regulatory Affairs Project Manager GlaxoSmithKline UK Uxbridge UK
Miss Rebecca Evans Regulatory Affairs Officer Wockhardt UK Wrexham UK
Mr Christopher Sharpe Chesham UK
Dr Michael Titus Maryland US
Miss Dunja Vukic Pharmacovigilance Associate PrimeVigilance Zagreb Croatia
Dr Jennifer Yen Cambridge UK
Ms Ana Zaccaro Regulatory Affairs Manager Takeda Global R amp D Centre (Europe) London UK
Registered Member
TOPRA welcomes the following new members who joined recently
Founder member receives certificateExecutive Director Lynda Wight and Alan Hunter Chair of the lsquoSTARrsquo Panelndash which ensures that success and achievement is recognised by TOPRA ndash visited the home of R Keith Greenwood to present him with his Honorary Life Membership certificate
Keith was a founder member of this organisation back in the 1970s and served as Chairman and leader of our Education efforts when some of our most important training initiatives were launched
He established the financial philosophy for the organisation that has ensured its continued stability and opportunity for growth He will be remembered with affection for his incisive and witty contributions to our conferences both from the platform and audience
In the wider world Keith was a pioneer in the emerging CRO industry and founded the Regulatory Affairs Journal Keith was awarded Honorary Life Membership some years ago but a bout of ill health now resolved prevented him from attending a presentation ceremony
Keith sends good wishes to his many friends in TOPRA and would be delighted to hear from them Contact the office for more information
Thank you VirginiaAfter several years as co-editor of InTouch Virginia Guellal is hanging up her shoes Her co-editor Greer Deal says lsquoVirginia has been such a pleasure to work with always professional and great fun I shall miss her emails sent in the early hours of the morning and her never-ending enthusiasm for her work and for our profession Thank you Virginia for your help and support lsquoIf you would like to join the InTouch editiorial team please email jeninetopraorg
Virginia with her daughter at a charity run last year
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