Medical Device Link.

Originally Published MX July/August 2004

INDUSTRY ASSOCIATIONS

New organization focuses on the changing reality of today's healthcare regulatory legislation and practice.

Brian James

In January of this year, a new global regulatory affairs organization was launched to meet the needs and aspirations of professionals involved in healthcare throughout the world. The Organization for Professionals in Regulatory Affairs (TOPRA; London) was established to fill a gap in the market for regulatory affairs training throughout the international community.

Brian James is TOPRA past-president elect and an associate with Interface International Consultancy Ltd. (York, UK), a firm that offers services in product development, regulatory affairs and compliance, and clinical study conduct for international pharmaceutical and medical device companies.

The world of regulatory affairs has changed enormously over the past 10 years. Whereas the approval processes for medicinal products used to have a focus that was exclusively national in scope, in recent years this scope has been broadened to a regional focus. To some extent, through the activities of organizations such as the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), there has even been a shift in the direction of a global focus.

It is TOPRA's intent to address the changing reality of healthcare regulatory affairs in three areas. First, the organization will provide its members with essential regulatory information that covers all major markets and is accessible wherever they are located. Second, TOPRA will take up the growing body of regulations in the fields of devices and complementary medicines by offering services and information relevant to these sectors. And finally, the organization will reflect the many changes in regulatory legislation and practice that have occurred in recent years, ensuring that its members are aware of the changes and their practical implications.

Filling a Gap in the Market

In the pharmaceutical and medical device industries, there is a lot of provision for training. In the case of regulatory affairs, however, the training that is offered tends to focus on top-line messages to the neglect of harsher operational realities. Keynote speakers at the April launch event for TOPRA—which took place simultaneously in London and Brussels via live satellite feed—illustrated precisely this point.

Speaking from Brussels, Philippe Brunet, PhD, head of the pharmaceuticals legislation and marketing authorization unit for the European Commission's enterprise directorate general, emphasized that legislators must communicate not only with the top level of regulatory professionals, but also with those working on the ground. "We have so far reached only what I would call the upper layer of the regulatory community," said Brunet. "Now it's very important to go down to every operational level both in the company and also in the different competent authorities." When the shape of new legislation or regulations hangs in the balance, he argued, it is crucial that such communication take place earlier than ever before, so that the practical experience of the 'doers' in industry can be taken into account.

Speaking from London, Daniel Brasseur, PhD, chairman of the committee for medicinal products for human use at the European Medicines Evaluation Agency, took Brunet's point about training one step further. It is not only the regulated who need training, he said, but the regulators too.

BIRA and ESRA to TOPRA

When it comes to conducting such training in regulatory affairs, the founding members of TOPRA have an enviable history that derives from the operations of the organization's two predecessor associations, the British Institute of Regulatory Affairs (BIRA) and the European Society of Regulatory Affairs (ESRA). Each of these associations was a pioneer in the field of regulatory affairs training, and each helped to elevate such training to the sophisticated and practical level that it holds today.

BIRA gave rise to ESRA as a response to the increasingly European focus of regulations for medicinal products. Although BIRA always maintained an international membership, misinformed individuals frequently assumed that this association was only for British professionals or that it dealt only with UK issues. Meanwhile, it gradually became clear that the members of both organizations viewed themselves as 'global' regulatory professionals, and that the two organizations were suffering from an extensive overlap in membership that would be inefficient in the long run. Consolidating, it seemed, was the best way forward.

The idea to replace BIRA and ESRA with a new global organization evolved at the organizational board level primarily in response to the many changes that have occurred in the regulatory affairs market. However, it was not lost upon the organizers that such a global group would also be more reflective of the 45 countries represented among their members.

Already, it is clear that TOPRA has begun to increase the influence of regulatory affairs professionals. For example, the European Commission has asked TOPRA to host its regulatory conference in the coming months. And the history of excellent meetings and publications compiled by BIRA and ESRA has enabled professionals to come to the new organization with confidence, knowing that it has a track record and financial stability.

TOPRA Activities

As an association of regulatory affairs professionals, TOPRA intends to conduct activities that will remain relevant to its varied membership. Members of the association include professionals from large multinational corporations, small biotech start-ups, independent consultancies, and regulatory agencies—all of whom need to keep in touch with the changing context of healthcare regulatory affairs.

Nevertheless, the organization does not pretend that it can be all things to all audiences. For instance, TOPRA will not seek to develop institutional positions with regard to the latest device safety or drug development issues. There are a number of very good national and regional associations capable of lobbying on behalf of industry, and the development of regulatory position papers is better left to such organizations. In any case, it would be difficult for TOPRA to represent the views of all its members in a single cohesive statement.

Even so, regulatory agencies have begun to invite TOPRA representatives to an increasing number of consultations and information days. Organization members have met with the Medicines and Healthcare Products Regulatory Agency on the subject of good clinical practices, and with the European Agency for the Evaluation of Medicinal Products on the subject of the new European clinical trials database (EudraCT).

Participation in such meetings will enable TOPRA to rapidly inform its members about new developments in their fields of interest. In turn, meetings of the organization will offer ample opportunities for networking among regulatory professionals, and an ideal setting for individual members to offer their views to individual regulators. On the basis of what they learn at TOPRA meetings, members may also choose to provide formal feedback on regulatory issues through their trade associations.

With legislation constantly being updated and new legislation being implemented, TOPRA will provide a means to prepare regulatory professionals for the transitional challenges they will face. In a recent example, TOPRA developed two instructional modules for training professionals about the European Union's Clinical Trials Directive, which was implemented in May of this year. Efforts such as this will remain the hallmark of TOPRA's activities, offering core training to prepare regulatory professionals for the impact of new legislation and associated regulations.

Future Plans

Over the past six months, TOPRA has introduced a number of innovations for its members. The organization has established a new advisory council, created a new Web site, launched a new journal titled Regulatory Rapporteur, and relaunched its regulatory affairs MSc and diploma programs (see sidebar, page 20). TOPRA is also working on new criteria for its continuing professional development programs, in order to raise the status of and build confidence in the regulatory profession.

In the future, the organization will continue to build upon its relationship with the European Medicines Evaluation Agency and to grow its new association with the European Commission. TOPRA has already begun planning for more international meetings to be held in 2005.

Making a Global Impact

Although the healthcare industry boasts a wide variety of regional and global organizations, some with specialized interests, TOPRA is the first global association with a specialization in healthcare regulatory affairs.

Because it is a global organization, TOPRA expects that its impact will be felt in many regions of the world. The organization's base in the European Union is already significant, and in the coming months TOPRA will also play a key role in training new members in the EU's accession countries.

TOPRA also has a growing presence and membership base in the United States, where members value the organization's intimate understanding of EU regulatory matters. To build on this base, TOPRA has initiated cordial discussions with the Regulatory Affairs Professionals Society so that the two groups may cooperate on future activities.

In the rest of the world, TOPRA claims journal correspondents from a wide range of countries, including Australia, Canada, China, India, Japan, Pakistan, and Turkey. Together, such corresponding members form a global network for regulatory news. In the future, TOPRA hopes to meet with local associations in these areas to determine how it might complement their offerings to members.

In all of these regions, TOPRA expects to carry forth its mission to raise the status and awareness of the regulatory affairs profession. The success of this mission will result in better-trained professionals throughout the world, and ultimately better regulatory performance by both company professionals and agency regulators. And that, TOPRA believes, is a bright future that's worth working for.

Copyright ©2004 MX