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What is TOPRA...

... and why does it matter to me?

The Organisation for Professionals in Regulatory Affairs (TOPRA) logo The regulatory affairs (RA) function in companies has evolved in the last three decades from one which passively collected and submitted data for submission to the regulatory authorities, to one which can proactively influence the whole product development process. Used well, the regulatory professional should give strategic advice to optimise time to market, gain the best approvals and keep the company compliant after marketing.

EU regulation has become increasingly complex at the same time that science and medicine has undergone revolutionary steps forward. The best regulatory professionals must take all this in their stride and work alongside their development and marketing colleagues to contribute to commercial success and improvements in patient care.

The Organisation for Professionals in Regulatory Affairs (TOPRA) was established to promote regulatory affairs as a profession, but also to provide education, training and information services to its members to help them to be the best they can as regulatory professionals.

TOPRA's focus is on European regulatory affairs and its membership is drawn predominantly from Europe, but increasingly North American RA staff are joining to learn more about the regulatory environment in the EU. Members come from big pharma, small and medium-sized enterprises, generics, biotech and device companies, regulatory agencies, contract research organisations (CROs) and support service companies; but all need up-to-date information and the ability to exchange ideas and experiences.

TOPRA offers a structured training programme for every level of experience, from new recruits to experienced professionals who need a 'refresher' on new legislation. The courses are delivered by experienced regulatory specialists from companies and authorities who can offer practical insight and real-life examples to reinforce learning and ensure it is current and applicable to the work environment.

The TOPRA Basics course is offered to those who work in other departments of the company, and helps them understand the purpose and role of the regulatory function, untangling the mass of acronyms and jargon, thus assisting co-operation between RA and other functions.

Pharmaceutical marketers have found this a useful means of finding out about EU regulatory systems and understanding some of the issues facing their RA colleagues – hopefully leading to more co-operative working back at the office.

At the other end of the training scale, TOPRA offers two MSc qualifications in regulatory affairs. TOPRA members can document their training and learning, from wherever it was obtained, through the TOPRA life-long learning scheme, giving their employers, colleagues or clients the reassurance that they take their personal and professional development seriously.

As well as formal training, TOPRA works with leading regulatory agencies across Europe to stage meetings on 'hot topics', where issues can be brought into the open and debated in a non-partisan and non-political way. In recent years, TOPRA has partnered with the regulatory agencies in Denmark, the Netherlands, Hungary, Sweden, and Austria and will work with the UK and Italian agencies in future.

Topics have included e-regulatory affairs and the introduction of the electronic Common Technical Document (eCTD), risk management, paediatrics and scientific advice. TOPRA also holds an annual meeting with EMEA and conferences with the EU Commission when new legislation is under development. In this way, TOPRA members become not only well-informed but also well-connected and can advise their companies with confidence.

All this training and education activity is supplemented with information services. TOPRA publishes a well-respected journal Regulatory Rapporteur which includes analysis of new legislation and has focus issues on topics of current interest. The website contains additional material including interviews with regulators, links to all agencies and a service directory.

So, why should TOPRA matter to pharmaceutical marketeers? Well, if your RA advisor is a TOPRA member, you can be sure they have access to the latest information and training opportunities. If they are active in TOPRA, they will have good connections with the right people and if they don't know something, then they'll "know a man who does".

And TOPRA is very clear that the most successful companies are those in which regulatory affairs and marketing understand each other, appreciate the purpose of the other function and work together in a constructive way. Regulatory affairs is no longer a 'sales prevention' department: it is the key to successful product launch and life-cycle development.

If you have never heard of TOPRA, now is the time to learn more by visiting www.topra.org. Ask your regulatory staff if they are members – and if not, challenge them to put that right!  

Contacts
TOPRA Ltd, 7 Heron Quays, Marsh Wall, London E14 4JB  Tel: +44 (0)20 7538 9502
email: info@topra.org
Training and education: For information, including sponsorship queries, email meetings@topra.org

6th August 2009

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