Wednesday, 1 October 2014

Regulators go public


The European Medicines Agency (EMA) has a key role in medicines regulation in Europe. Part of its role is to coordinate the EU's safety-monitoring or 'pharmacovigilance' system for medicines. The Agency monitors the safety of medicines through the EU network and can take action if there is a safety concern. Its Pharmacovigilance Risk Assessment Committee (PRAC) provides recommendations on the safety of human medicines. Recently, the EMA launched a public consultation on draft rules of procedures for public hearings held by PRAC. Citizens have been invited to review the proposed draft rules and send their comments to the Agency.

One of the difficulties for outsiders is that it is hard to understand why the EMA arrives at particular decisions and what goes on behind the scenes regarding its processes. Not surprisingly, from time to time the regulators come in for criticism from physicians, industry and the public regarding transparency. In recent years there have been an increasing number of requests from outside parties for access to data that the EMA reviews on products.

The EMA has an ongoing commitment to providing greater clarity and openness in all areas of its operations. It has developed a transparency policy, which aims to promote a proactive approach to transparency in the daily operations of the Agency and submitted this for public consultation. It also held workshops to enable the draft policy to be discussed with stakeholders. The recent launch of a public consultation regarding PRAC is therefore part of a trend by the EMA to show that it is open and welcomes external views. Across the Atlantic, the Food and Drug Administration (FDA) has a more established reputation for holding events open to the public, although this does not prevent external criticism regarding its approach to transparency. One key opportunity for the public to engage with FDA is during the open public hearing (OPH) session of an advisory committee meeting. FDA’s advisory committees serve an important role in providing independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to products. The FDA has issued guidance on how individuals can participate in these public hearings.

Patients are increasingly involved in decisions regarding their health and so regulators will need to show that they are willing to proactively engage with the public regarding their decisions. The EMA has stated that since patients will ultimately be the ones taking the medicines they review, it would be logical to incorporate their knowledge into the regulatory process. However, in the absence of well-publicised mechanisms such as the FDA’s public hearings, European regulators face difficulties in proving that they really are open to external views.

Latest Regulatory Affairs jobs

Tuesday, 9 September 2014

Expanding role for NICE as HTA takes hold in the UK

The UK’s healthcare system is primarily public, but rising healthcare expenditure coupled with increasing demand is placing a strain on the system. For example, according to the Office for National Statistics, expenditure on healthcare in the UK rose from £54.8 billion in 1997 to £142.8 billion in 2011. These trends, which are not unique to the UK, have led to the use of Health Technology Assessment (HTA) to determine what represents value for money at the national level for healthcare services.

Since its establishment as a Special Health Authority in 1999, the National Institute for Health and Care Excellence (NICE) has become one of the leading organisations involved in HTA. Its stated role is to provide evidence-based guidance and advice for health, public health and social care practitioners. In effect, NICE aims to give independent advice about which treatments should be available on the NHS in England and Wales. The organisation often receives criticism in the media regarding its decisions and pharmaceutical industry representatives have been wary of NICE and believe that reforms of the UK’s approach to HTA are needed. However, NICE has also received several favourable reviews from independent agencies including the House of Commons Health Committee, the World Health Organization and independent academics.

In recent times, controversial NICE decisions regarding Alzheimers and cancer drugs have led to considerable negative media coverage and complaints from patients, but despite this, its role within healthcare is expanding. Reforms have seen the organisation expand its work into areas such as social care and it will be central to the introduction of value-based pricing (VBP), where the value of a drug will be based on an assessment of the evidence available and will directly influence how the manufacturer is reimbursed.

In order to respond to its critics, NICE has highlighted its commitment to transparency. On its website it features a number of opportunities for stakeholders to contribute to the development of its recommendations. In addition, it runs scientific advice seminars, where manufacturers of drugs, medical devices and other technologies and other interested parties can learn more about NICE’s processes and what its assessors expect from submissions. The success of these seminars has led to requests from other organisations for partnerships with NICE in order to reach a wider audience of developers, particularly at international events. Companies can also book a site visit where the NICE team can explain in greater detail the organisation’s scientific advice services.

Latest HTA jobs

Friday, 22 August 2014

Uncertainties over Biotech

While major pharmaceutical companies dominate industry R&D and new drug output it is important not to overlook the contribution that smaller companies make to their drug pipelines. In particular, the biotech industry has been an increasingly popular source of products for companies looking at licensing options. The need for new products has grown as some of the larger companies face several patent expiries for major products.

European governments also realised that a vibrant biotech sector could contribute to the economy and act as a generator of employment. Therefore, several governments attempted to boost the biotech sector through measures such as tax incentives. When R&D is at an early stage, investors can be hard to find and so government support measures are crucial for companies. Nevertheless, in the longterm, external funding from investors and deals with larger companies are the main requirements for biotech company growth. In these respects, European companies still struggle forfunding compared with their US rivals.

Sadly, the European sector has started to experience a decline in support because of the region’s economic problems. A number of national governments may be wavering in their commitment to the sector. This national government uncertainty is at odds with the official EU Strategy for 2020 which is focused on increasing productivity and specifically mentions small and medium enterprises (SMEs), such as those in the biotech sector, as playing a key role in achieving regional growth.

The clinical impact that the current generation of biotech products have had illustrate the exciting potential that biotechnology has to tackle disease. For example, before the advent of the interferon beta MS treatments, the condition had received inadequate attention, much to the disappointment of patients. However, the growing use of biotech drugs is also driving up the costs involved for medical treatment and some healthcare systems have shown a reluctance to provide the necessary funding.

In the current European economic climate, the funding of new biotech treatments has become a particularly contentious issue. Originator companies state that the high price of biotech therapies is because they must recoup their heavy R&D investment, but this argument has not been enough to satisfy politicians. As a result of rising costs, some European governments have been looking at controversial ways in which they can slow spending on these types of products. The impact of these types of interventions will have a strong bearing on the outlook for Europe’s biotech sector.

Wednesday, 23 July 2014

Tackling the under representation of the elderly in clinical trials

The pharmaceutical industry will need to adapt its R&D efforts to the requirements of the growing elderly population. In the US it has been predicted that by 2030, the elderly will represent 20% of the population and in Europe they may represent a quarter of the population. The World Health Organization believes that companies need to focus more on developing patient-centred rather than disease-related measures in order to satisfy the ‘real’ needs of a global ageing population.

One of the challenges companies must overcome is that the elderly are under-represented in clinical trials. This means that the scientific evidence base for many medicines used for the elderly is rather small, which makes it difficult for physicians to have confidence in what they prescribe. A number of European geriatricians have gone as far as to launch a charter against ageism in clinical trials, highlighting that practical issues in involving elderly in clinical trials are not the only reason for such observations. Their views are the result of their involvement in the European-wide PREDICT (Increasing the PaRticipation of the ElDerly In Clinical Trials) consortium. The consortium members are based in the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the United Kingdom and co-ordinated from Medical Economics & Research Centre Sheffield, UK.

The aim of PREDICT is to investigate reasons for the exclusion of the elderly in clinical trials and to provide solutions for this problem. The group published some of its conclusions in a peer-reviewed paper in the Archives of Internal Medicine, which focused primarily on the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure.

The European Medicines Agency (EMA) has also taken account of the demographic implications of ageing. It has engaged with other regulators, pharmaceutical companies and organisations representing the interests of elderly people in Europe in order to improve the current situation. In March 2012 it held a two-day workshop to discuss the EMA’s geriatric medicines strategy and related activities, so that gaps in the strategy could be identified. The EMA hopes that a presentation of its strategy in this field will provide opportunity for the identification of synergy areas between stakeholders. The Agency has also participated in other initiatives focused on geriatric medicine. In July 2013, UCL hosted a public engagement workshop, which featured members of the geriatric community, family carers, professionals from academic research, industry and regulatory agencies.

Although the elderly are currently under represented in clinical trials, the ongoing discussions between stakeholders suggest a more optimistic future. Those behind PREDICT highlight that an analogous problem occurred in thepaediatric population but research in this domain has considerably improved and therefore offers an example of what can be achieved through dedicated efforts focusing on special populations.

Saturday, 5 July 2014

Will healthy ageing become a reality?

In the EU by 2025 more than 20% of Europeans will be 65 or over, with a particularly rapid increase in the number of over 80s. A major challenge for European governments is how to meet the higher demand for healthcare and ensure that healthcare systems meet the needs of the elderly.

The elderly have markedly different healthcare requirements to younger age groups but, at present, many services are not ideally tailored to suit their needs. For example, it has long been known that the elderly use a greater amount of medicines than younger patients. In a survey by the US National Center for HealthStatistics it was reported that 80% of the elderly population (adults aged 65 years and older) took at least one prescription drug in the prior month. The issue of polypharmacy is a particular concern in the elderly, who compared to younger individuals, tend to have more disease conditions for which medicines are required.

The European Commission’s (EC) official position is to actively support Member States in their efforts to promote healthy ageing through dedicated initiatives to improve the health of older people. There is a belief that an ageing population in good health will also mean less strain on health systems and fewer people retiring from work due to ill-health. At present, the European Innovation Partnership on Active and Healthy Ageing aims to ensure that the average European citizen has two more active and healthy years to live by 2020. The EC takes the view that ageing is an opportunity for Europe rather than a hindrance. However, Europe’s continuing economic crisis is creating uncertainty regarding the plans to improve healthcare for the elderly as governments are reluctant to invest in new areas. The experience in Greece serves as awarning of what can happen in the face of economic problems. As a result of the economic meltdown, doctors' wages in the public system have been cut in line with other government workers, and hospitals are at risk of being merged and face regular shortages of materials.

The ongoing economic difficulties in Europe may hinder investment in additional healthcare services for the elderly since politicians are looking to implement cutbacks. However, it must be remembered that the elderly also represent a growingproportion of the voting population and will therefore not accept their long-term healthcare needs being ignored.

Sunday, 22 June 2014

Involving patients in medicines regulation

Medicines are developed to benefit patients, yet historically, their views have been overshadowed by the views of healthcare professionals. Regulators have tended to follow this pattern too, but are now committed to fully involving patients in decision making wherever possible. The move of patients from being a passive voice in healthcare to an active one has helped bring about this change. Patients have not only become better informed, but also increasingly vocal in what they desire in terms of healthcare. A number of patient groups have formed worldwide alliances to represent their views.

Patients have been involved in the development of new regulations around the world, but not in a consistent manner. The AIDS crisis led to considerable patient pressure being placed on regulators in the US to ensure that new medicines were developed. Similarly, the legislation concerning orphan medicinal products for rare diseases has been greatly influenced by the work of patient groups in the EU, US and other regions.

Historically, the US has been seen as further ahead in recognising the views of patients in medicines regulation. The FDA has a section called the Patient Network, whose role is to ensure that the perspectives of patients, family members, caregivers, and patient advocates are not overlooked during the review process. The FDA also put in place a Patient-Focused Drug Development (PFDD) program to systematically involve patients and this features regular meetings for different disease areas. The European Medicines Agency (EMA) has interacted with European patients since it was founded in 1995, but is seeking to formalise this type of engagement. The Agency works via a network of over 30 European patients’ and consumers’ organisations that must fulfil certain eligibility criteria. There is a framework to direct how interactions between regulators and these groups take place. Currently, patients can be asked to become involved in a variety of activities, ranging from taking part in scientific advisory groups to being involved in the preparation of guidelines. The EMA Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) was established to provide recommendations on all matters of direct or indirect interest to patients.

In September 2013, the EMA held a workshop in London that brought together representatives of patients, consumers, healthcare professionals and the pharmaceutical industry with members of the EMA’s scientific committees and staff. The aim was to get a better understanding of how patients could become further involved in the assessment process for medicines, particularly when it came to benefit and risk evaluation. The EMA appears committed to further involving patients in its activities and will be using the outcomes of the workshop to make further improvements to its processes. Presently, it produces an annual report on its involvement with patients that includes a satisfaction questionnaire.

Thursday, 29 May 2014

The Regulator’s balancing act

Many patients as well as those in pharmaceutical companies can become frustrated with regulatory agencies when a decision does not match their views. Yet however difficult these regulatory setbacks are to accept, it is important to remember that regulatory agencies are government bodies and are therefore ultimately accountable to the public. For example, in Japan, the cancer drug Iressa (gefitinib) caused a series of adverse events in patients and a number of people died from pneumonia-like illnesses. The country’s regulatory body, the Japanese Ministry of Health, Labour and Welfare (MHLW), was publicly criticised over its role in the approval of the drug. In the US, One of the most damaging episodes for the US Food & Drug Administration (FDA) was Merck’s COX-2 inhibitor Vioxx (rofecoxib), which was withdrawn from the market after being linked to an increase in the risk of heart attacks and strokes.

Public safety is paramount and so decision-making within regulatory bodies must be geared towards this factor rather than external expectations. The European Medicines Agency’s (EMA) own mission statement states the Agency’s intention to “foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public.” The FDA describes its role in similar terms in its Mission Statement.

Ironically, regulatory agencies are often accused in the media of being too “close” to the pharmaceutical industry and have even been sued by consumer groups. Regulatory agencies must constantly find a balance in dealing with the pharmaceutical industry so as to encourage drug development but also demonstrate to those outside the industry that their decisions are impartial and transparent. Reviewers must weigh the information available about a drug’s risk and benefit, make decisions in a limited time in the face of scientific uncertainty, and integrate emerging information bearing on a drug’s risk-benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. Regulatory processes may have life-or-death consequences for individual patients, and for drugs that are widely used, they may also affect entire segments of the population. Reviewers must therefore strike a delicate balance in judging the drug’s risks and benefits, and whether the need for more information from studies to increase certainty before agency approval, warrants delaying the release of the drug into the marketplace and into the hands of health care providers and their patients.

Latest regulatory affairs jobs

Thursday, 22 May 2014

Pharma’s important role as an employer

As well as being a major producer of medicines, the pharmaceutical industry is a vitally important contributor to the economy, particularly as an employer. For example, in the US, the sector employs more than 810,000 workers and indirectly supports a total of 3.4 million jobs across the country. In the UK, the industry employs around 68,000 people of which 23,000 work in R&D. According to the European Federation of Pharmaceutical Industries and Associations, the industry directly currently employs 660,000 people in Europe and generates between 3 to 4 times additional employment indirectly. Therefore, while many European governments have focused on cost containment measures as a means to curb healthcare spending they remain nervous about putting too much pressure on pharmaceutical companies because of the impact it might have on their investment in the region.

Companies have been grumbling for a number of years about the tough operating conditions in Europe and hinting that they may shift investment to other regions, particularly emerging markets. Over the past few years there have been a series of high profile job cuts in the European pharmaceutical sector, with companies linking such measures to the unfavourable operating environment. For politicians these measures could not be taking place at a worse time. With Europe in the midst of economic crisis and governments struggling to create new jobs, the role of the pharmaceutical industry as a major employer is critical to economic recovery.

The wide-ranging impact of a pharmaceutical company’s decision to cut jobs is illustrated by Pfizer’s 2011 closure of its R&D base at Sandwich, Kent. Unions complained about the government’s economic cutbacks and highlighted that the jobs being lost at Pfizer’s facility were the type that the UK needed to preserve for economic recovery and that the move would devastate the local region.

The UK is not the only country where national politicians have found themselves under pressure as a result of pharmaceutical industry job cuts. France has been experiencing a similar situation due to Sanofi reorganising its global operations. In July 2012, the national newspaper Le Figaro reported in July 2012 that up to 2000 jobs might go as part of a Sanofi drive to reduce the workforce. The French government was forced to reacted quickly, as it was already facing considerable public criticism for being unable to kickstart the economy and due to imminent job cuts in the automotive sector. It held behind the scenes discussions with Sanofi which led to the company announcing that it would cut fewer jobs and a commitment to maintaining its existing sites in France.

European governments need to be mindful regarding potential job cuts within the pharmaceutical sector and engage with companies to safeguard employment. In late 2012, GlaxoSmithKline’s CEO painted a depressing picture regarding company’s view of the European market, with analysts linking such statements to future job losses.

Latest pharmaceutical jobs

Thursday, 17 April 2014

So how do you name a drug?

Given the huge investment needed to get a drug onto the market and the sophisticated, expensive launch campaign that follows, it is unlikely that companies would take the naming of their product lightly. Stories abound regarding products in other industries where names have been a disaster, particularly when a product name has been adapted for use in a foreign market. Apart from avoiding embarrassment, given the growing number of medicines on the international market, as well as others emerging from product pipelines, it must be difficult to find something new that does not sound like something else. There is always the safety angle to be aware of since prescribing errors due to name similarities are a big healthcare problem. In addition, the naming process needs to follow certain guidelines outlined by regulators.

As every company closely guards the specifics of their methodology for naming new drugs, it is hard to determine what the common points might be between different company approaches. Nevertheless, some insights and clues have appeared in the industry media. For example, it is clear that companies start thinking about their brand name very early on in development. Clearly a product name should be one that is easy to remember, hopefully straightforward to pronounce and one that subtly gives healthcare professionals a favourable impression (so that they think of it rather than a generic name). Marketers seem to love names that generate emotion and a whole host of branding agencies have done very well in this line of business.
A number of the names sound a bit space age, using letter such as X, Z, N, Q or K. It has been suggested that these hard sounds convey the impression of cutting edge science. Not surprisingly, if we consider things from a marketing perspective, softer sounds seem to be in use for women’s products – using letters such as S, M, V, L or R.

It is easy to be critical that so much time and money is spent on developing a drug name and the touchy feely marketing aspects probably make most people cringe (…you can have a go yourself by trying the online Drug-O-Matic Name Generator). No one wants to feel that they are influenced in any other way to think of a medicine than by the hard scientific and medical data available. Then again, for the Top 25 Best-Selling Drugs how quickly can you name and accurately spell their generic names?

Latest sales & marketing jobs

Thursday, 10 April 2014

Everyone’s talking transparency

We are hearing a lot about transparency these days. Regardless of the sector you work in, everyone is very keen to show that they have nothing to hide. In the world of pharma a big talking point is transparency regarding clinical trial data, driven by longstanding concerns over the selective publication of trial results. The worry is that unless all data for clinical trials are available then no one really knows on what basis clinical decisions about new drugs and other healthcare interventions are made. Several campaigners have suggested that selective reporting of trial results has already had a negative impact on patient health outcomes and that this situation is no longer tolerable. Now with media attention focused on specific examples of drug companies’ perceived reluctance to publish data on all their drug trials, coupled with the persuasive messages from the Alltrials campaign, things are set to change.

There has been a tendency in the past by various industry parties to view clinical trial data as “their” data and put forward technical justifications as to why only certain clinical data is published. However, campaigners for transparency have pretty well scuppered this position by pointing out that since patients are involved, they did not get involved in trials just for the results to stay hidden in some vault. This ethical and moral argument is one that resonates far better with the public than the laboured approach that many industry representatives use. Complicating the industry position further is the fact that some major companies are now publicly backing the Alltrials campaign.


However, what is really set to cause a big stir is the European Medicines Agency’s (EMA) impending policy on the proactive publication of clinical trial data. European regulators have not always been the best of friends with campaigners for data transparency, but the EMA’s current position will be hugely influential on how things develop from here. At the moment, a final round of consultations with key stakeholders is taking place and a final version is likely to be endorsed by the Agency’s management in June. When this policy is released, the impact is likely to be global. Already, there are signs that other regulatory agencies are reviewing their approaches to transparency. Greater data transparency is inevitable, but the measures to ensure that data are released and used in the right way so that patients actually benefit from the more open environment are still to be defined.

Thursday, 3 April 2014

To MOOC or not to MOOC?


OK admit it,you don’t know what a MOOC is and what it stands for, but you keep hearing everyone talk about it. It sounds nerdy though, right? Well, don’t be alarmed as it isn’t a weird alien from Star Trek (…apparently there was a profitable pharma industry in Star Trek. In fact a MOOC is a concept that’s being debated as a way to revolutionize education.

MOOC stands for
Massive Open Online Course and as the full name states is designed to make education accessible wherever you are. Supporters of MOOC have even optimitstically claimed that they will make education “borderless, gender-blind, race-blind, class-blind, and bank account–blind 


If you cut through the jargon, a MOOC basically uses modern technology to deliver an educational course online for free. Many MOOCs appear to be slimmed down versions of modules that might feature in a degree. Learning takes place in a kind of distance learning format, often with video-based lectures and via a website for group course work and assessments (including quizzes and exams). However, there seem to be no entry requirements, no fixed structure for the educational content, no set length and no universally accepted standard certification. Also there is no sign that MOOCs will replace mainstream qualifications (i.e. what you need for a job!). 


If you have no initial set ideas in choosing a MOOC, then you can become a bit overwhelmed by what’s on offer. It’s a bit like your “eyes being bigger than your stomach” when you are faced with the opportunity for a fantastic meal. The fact is that you can study anything – yes truly anything! The list of MOOCs on offer is truly mindboggling and is growing by the day – ranging from areas such as quantum physics, ancient history and corporate finance – through to more unusual subjects such as card magic tricks and knitting socks


If you are in the pharmaceutical industry, all you have to do is sift through this giant list and you will find courses that are ideal for areas you want to know more about. So yes, it is possible for you to ditch the opportunity to pursue underwater basket weaving and instead learn about more career-related areas such as drug discovery and development, clinical trials, medical statistics, healthcare ethics, health technology assessment (HTA) or current global health challenges. Some MOOCs could even help you figure out where you want to work in the pharma sector


If you are interested in educating yourself in new areas then MOOCs can be an excellent way to achieve this at no cost. You may not be able to convince your employer to accept the self assessment certificate you gain from a MOOC as a substitute for a formal qualification but they might be impressed by your new-found knowledge on a subject. However, be warned that hard work is needed if you want to get the best from a MOOC and that if you don’t motivate yourself no one else will. Although thousands of people often sign up to popular MOOCs, the completion rate for courses remains shockingly awful – often 90% do not finish.

Wednesday, 26 March 2014

World Tuberculosis Day 2014 passes with a glimmer of hope

Even though tuberculosis kills 1.4 million people each year it is often thought of as a disease of the past. However, it is a very present danger, and is one of the three main killer infectious diseases (along with malaria and HIV/AIDS). One reason that it has been overlooked is that its main impact is in developing countries. Tuberculosis and poverty create a vicious cycle, whereby the disease exacerbates poverty and this in turn increases the possibilities of contracting the disease.

One estimate suggests that tuberculosis will effectively rob the world’s poorest countries of an estimated US$1 to US$3 trillion over the next 10 years. This “draining” economic effect means that it is very difficult for these countries to advance and improve conditions. The World Bank has put the loss of productivity due to TB at somewhere between 4 to 7 percent of some countries' GDP. At a community level, the economic burden of illness for households has been described as catastrophic.

Given the threat posed by the disease, greater efforts are being made to rectify the problems and complacency of the past. In particular, the World TB Day initiative, held on 24 March each year, has attracted a lot of media attention. This campaign produces a range of information in different languages (Arabic, Chinese, English, French, Russian and Spanish) to maximize its global impact.

Another area where progress is needed is in the area of drug development. The track record for new anti-tuberculosis drugs has been pitiful. New advances are badly needed as drug-resistant forms of the disease are a major health problem and current therapies are not adequate to deal with the situation. As tuberculosis offers low rates of commercial return, it has been of little interest to most pharmaceutical companies. The perceived lack of interest of pharmaceutical companies to go it alone in this area has prompted the idea that R&D partnerships with the public sector and other organizations might be a better approach. For example in 2007, seven pharmaceutical companies announced that they would team up with four research institutions and work with the Bill & Melinda Gates Foundation to create a partnership called the Tuberculosis Drug Accelerator (TBDA). Since then, other companies have joined this unique partnership. The TB Alliance, established in 2000 as a not-for-profit product development partnership, has played a major role in trying to deliver innovation for this area. At present, TB Alliance and its partners manage the largest pipeline of TB drugs.

The regulatory agencies also have a role to play in ensuring that new drug development is encouraged. In Europe, there has been a welcome step forward recently, with the European Medicines Agency having recommended granting marketing authorization to three medicines for the treatment of multidrug-resistant tuberculosis. US regulators have also been actively encouraging this field, with one product having benefitted from a number of the agency’s incentives.

There is no doubt that some progress is being made in tackling the disease, but the scale of the challenge is huge. Worryingly, there are signs that tuberculosis is gaining a firm foothold in a number of major European cities. A lot more will be expected in terms of new advances by the time that World TB Day 2015 comes around.

Latest infectious diseases jobs

Friday, 21 March 2014

It’s not all doom and gloom if you want to get into regulatory affairs

Job in regulatory affairs
No company can succeed these days unless it has a really good regulatory affairs department. This hugely important, but rather misunderstood, function sits at the interface between the company and health authorities and acts as the contact point for regulatory agencies regarding a company’s product.  

As a regulatory affairs professional you have to not only understand different aspects of product development, but also be able to provide input on how data can be used to support registration in numerous countries. This also means spending a lot of time in keeping up to date with changes in regulations in different markets. Nowadays, while an understanding of the regulatory agencies of the US, EU and Japan is still key, you may find yourself dealing with markets further afield such as China, India or Brazil.

As the regulatory affairs function has a multidisciplinary element to it there seems to be no set route into roles in the profession. For an interested newcomer it can be quite confusing to work out where to start to enter this field, particularly since it is changing all the time. Unfortunately, many people you meet working in regulatory roles come from such diverse backgrounds that their career path might not work for you.  As a job seeker, you can feel quite disappointed because there seems to be a general lack of interest in people who do not already have regulatory experience.

Thankfully, the area has grown so much in stature within the healthcare sector that there are now professional organisations to help regulatory professionals. Two such useful organisations are The organisation for professionals in regulatory affairs (TOPRA) and the Regulatory Affairs Professionals Society (RAPS). They are playing an increasingly important educational and networking role. Both these organisations actively seek to promote regulatory affairs as a profession and so are good places to figure out if this area is for you and help you develop your career. They have courses to give you a solid foundation in regulatory affairs and also run conferences where you can hear from senior regulators. Another useful organisation is the Drug Information Association (DIA).

General news websites running articles and news, and the websites of the major regulatory agencies are great places for self-education. While some information is highly technical and aimed at specialists, a lot is clearly introductory with the intention being to demystify what goes on. You would be surprised to see what sort of information they have – for example, the FDA has a fascinating section on its history which helps you understand exactly why the regulatory affairs profession has evolved to become what it is today. Also both the FDA and EMA manage a number of social media channels.

If you want to get into regulatory affairs you need to be both self-motivated and proactive to make headway.  The route might not be straightforward but there is a lot you can do for yourself.

Browse the latest regulatory affairs jobs