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TOPRA

Healthcare Regulatory Affairs

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TOPRA

TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector.

Our current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

Healthcare regulatory affairs training and development

TOPRA is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education, and provision of information to its members. Members have the advantage of a structured training programme available to them at preferential rates.

This programme ranges from intensive Introductory Courses for new entrants to the profession, through detailed practical courses on topics of interest to those with a few years’ experience, to an MSc qualification. There are also management courses designed specifically to meet the challenges of the regulatory professional as his or her career develops. The training programmes are highly regarded and internationally recognised in the Regulatory Affairs profession.

Healthcare regulatory affairs news and resources

Members also have access to an international journal giving the latest news and comment on current regulatory matters as well as a variety of services including breaking news, industry links, and career opportunities to list but a few. Through the website, journal and direct mail services, members are kept advised of new career opportunities in the field and the salary survey is a useful tool for all in the profession.

Professionals in regulatory affairs

Just by being a member of TOPRA, an individual signals a commitment to their career in Regulatory Affairs and a serious approach to the difficult task of keeping up-to-date in this rapidly changing environment.

The work of TOPRA is supported by dedicated office staff, but driven by the involvement and commitment of the members themselves. The input of members, whether they be employed by companies, consultancies, regulatory agencies or acting as freelancers, is vital in ensuring that all members gain the maximum benefit from their membership.

To find out about the benefits of TOPRA membership please click here.

TOPRA
Bellerive House
3 Muirfield Crescent
London
E14 9SZ
Tel: +44 (0) 20 7510 2560
Fax: +44 (0) 20 7537 2003
topra@topra.org
www.topra.org

Continuing Professional Training in Regulatory Education

Those who have a couple of years practical experience and who may have undertaken the Introductory Course early in their career will inevitably assume new responsibilities or change direction and so be required to perform tasks that need them to have additional knowledge. The TOPRA CRED Programme and PRA Workshop are designed to meet this need.

The programme comprises a series of one-day interactive workshops, run over a two-year cycle, and offers: Structured, but flexible, continuing regulatory education – allowing regulatory professionals to design training programmes to suit individual needs A choice of sixteen interactive workshops, covering eight core topics, run over a two-year cycle – providing regulatory professionals the opportunity…

Current Awareness in Regulatory Affairs

As well as the requirement for a 'refresher' course on basic regulatory topics, there is also a need, particularly for more senior professionals, to have an overview of some of the emerging issues of the day.

In the past, TOPRA has dealt with all of these in the same way - by planning a full-day programme involving the leading names in the regulatory agencies and industry to deliver their perspective in a series of presentations with a significant amount of time devoted to panel sessions and Question and Answer sessions. For…

Introductory Course: Current EU Regulatory Practices

The Regulatory Affairs function within the pharmaceutical industry is absolutely pivotal to the successful development and licensing of safe and effective medicines, to the benefit of patients' health worldwide. The TOPRA Introductory Course is chosen by Regulatory Affairs Managers who wish to get their people up-to-speed on current EU regulatory practices.

The Course looks at the bigger picture, focusing not only on EU legislation and regulatory procedures, but also on the central role that Regulatory Affairs plays in a modern pharmaceutical company and in the development of new drugs. The Course will also include the valuable insight from experienced speakers who grapple daily with the challenges…

MSc in Medical Technology Regulatory Affairs

In today's competitive environment the reduction in the time taken to reach market is critical to a product's – and hence a company's success. The proper conduct of its regulatory affairs activities is, therefore, of considerable economic importance to a company.

Events such as failure to fully report all necessary data in the approval process or launch of a product bearing incorrect labelling, may easily result in the need for a product recall. A good regulatory affairs professional plays an important part in coordinating scientific endeavour with regulatory demands throughout the life of a product and…

MSc in Regulatory Affairs

The MSc in Regulatory Affairs offered by TOPRA and validated by the University of Wales, provides a unique opportunity to study aspects of regulatory affairs at an advanced level.

The MSc Degree in Regulatory Affairs was introduced during 1989. This course is designed for professionals working in Regulatory Affairs who have already gained first-hand experience of handling regulatory issues. Such experience may be in one area of Regulatory Affairs that could be developed and broadened by studying for the MSc. Alternatively, your experience may…

Publications

Members have access to an international journal giving the latest news and comment on current regulatory matters. In addition to the website and direct mail services, the journal keeps members advised of new career opportunities in the field and the salary survey is a useful tool for all in the profession.

Working in a rapidly changing legislative environment and for an industry where scientific advances are being made daily, regulatory professionals need to be sure they have the latest information – not only about recently introduced developments, but also those anticipated to come in the next few years! Sourcing information in today's technological environment is easy;…

Course: Basics of Regulatory Affairs

A one-day introductory course for very new recruits, PAs, administrators and support staff in Regulatory Affairs. Suitable for staff in agencies and companies. This course is now in its 14th successful year.

2010 Dates: Wednesday 10 February 2010 Wednesday 24 March 2010 Wednesday 19 May 2010 Wednesday 11 August 2010 Wednesday 20 October 2010 Venue: Danubius Hotel, 18 Lodge Road, London, NW8 7JT. The purpose of the day The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry…

The TOPRA Annual Symposium

TOPRA's highly successful Annual Symposium, which builds upon a 30 year track record in delivering the premier annual Regulatory Affairs conference for Europe attracts excellent high-level speakers.

These speakers include government Ministers, Heads of Agencies, key officials from the European Commission, Heads of Unit from EMEA, leading pioneers and practitioners from within industry, pan-European policymakers, patient groups and consultants who examine topical issues in European and global regulatory affairs. The TOPRA Symposium provides a forum for detailed discussion of all the most…

TOPRA e-learning

Topra-elearning is an online training resource that contains a range of courses designed to help with your personal and professional development. Lifelong Learning (LLL), also known as Continuing Professional Development (CPD) plays an important part in most professional bodies.

There are a number of TOPRA elearning courses available covering the broad areas of Managing people, HR and Compliance, Personal effectiveness, Professional skills and Sales and marketing, including: Negotiation Skills Principles of Consultative Selling Project Management Conducting Performance Appraisals Leadership Skills Managing High Performing Teams All the courses have been tailored specifically for TOPRA members,…

The Benefits of TOPRA Membership

A detailed list of TOPRA membership benefits.

Publications Every member of TOPRA receives the international journal Regulatory Rapporteur on a monthly basis. The journal is a high-quality publication, which includes the latest regulatory news, interviews with leading figures and analysis. It also includes the latest meeting and conference reports and a wealth of valuable material to help with the day-to-day work of…
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