Five Things You Should Stop Doing in 2012

I recently got back from a month's vacation — the longest I've ever taken, and a shocking indulgence for an American. (Earlier this summer, I was still fretting about how to pull off two weeks unplugged.) The distance, though, helped me hone in on what's actually important to my professional career — and which make-work activities merely provide the illusion of progress. Inspired by HBR blogger Peter Bregman's idea of creating a "to ignore" list , here are the activities I'm going to stop cold turkey in 2012 — and perhaps you should, too.

1. basically a slot machine for your brain. But spending a month away — and only checking email weekly — showed me how little really requires immediate response. In fact, nothing. A 90 minute wait won't kill anyone, and will allow you to accomplish something substantive during your workday.
2. Mindless Traditions. I recently invited a friend to a prime networking event. "Can I play it by ear?" she asked. "This is my last weekend to get holiday cards out and I haven't mailed a single one. It is causing stress!" In the moment, not fulfilling an "obligation" (like sending holiday cards) can make you feel guilty. But if you're in search of professional advancement, is a holiday card (buried among the deluge) going to make a difference? If you want to connect, do something unusual — get in touch at a different time of year, or give your contacts a personal call, or even better, meet up face-to-face. You have to ask if your business traditions are generating the results you want.
3. Reading Annoying Things. I have nearly a dozen newspaper and magazine subscriptions, the result of alluring specials ($10 for an entire year!) and the compulsion not to miss out on crucial information. But after detoxing for a month, I was able to reflect on which publications actually refreshed me — and which felt like a duty. The New Yorker , even though it's not a business publication, broadens my perspective and is a genuine pleasure to read. The pretentious tech publication with crazy layouts and too-small print? Not so much. I'm weeding out and paring down to literary essentials. What subscriptions can you get rid of?
4. Work That's Not Worth It. Early in my career, I was thrilled to win a five-year, quarter-million dollar contract. That is, until the reality set in that it was a government contract, filled with ridiculous reporting mechanisms, low reimbursement rates and administrative complexities that sucked the joy and profit out of the work. When budget cuts rolled around and my contract got whacked, it turned out to be a blessing. These days, I'm eschewing any engagement, public or private, that looks like more trouble than it's worth.
5. Making Things More Complicated Than They Should Be. A while back, a colleague approached me with an idea. She wanted me to be a part of a professional development event she was organizing in her city, featuring several speakers and consultants. She recommended biweekly check-in calls for the next eight months, leading up to the event. "Have you organized an event like this before?" I asked. "Can you actually get the participants? Why don't you test the demand first?" When none materialized, I realized I'd saved myself nearly half a week's work — in futile conference calls — by insisting the event had to be "real" before we invested in it. As Eric Ries points out in his new book The Lean Startup , developing the best code or building the best product in the world is meaningless if your customers don't end up wanting it. Instead, test early and often to ensure you're not wasting your time. What ideas should you test before you've gone too far?

Eliminating these five activities is likely to save me hundreds of hours next year — time I can spend expanding my business and doing things that matter. What are you going to stop doing? And how are you going to leverage all that extra time?

Novartis Confirms Patient Died After Starting Gilenya

QNovartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Whether Gilenya played a role in the patient’s death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.

“In the case of MS drugs, there is often significant safety baggage of different sorts,” Anderson wrote. He rates Novartis’s shares “outperform” and estimates that by 2015 Gilenya sales will reach $1.4 billion, about 2 percent of the Swiss company’s revenue.

The exact cause of the death hasn’t been established, Novartis said. Sudden death “smacks of being cardiovascular in nature,” Anderson wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.

The patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose, Althoff said.

Novartis said it has sent details of the case to the U.S. Food and Drug Administration and other regulatory authorities.

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Naomi Kresge at nkresge@bloomberg.net

Career Spotlight: Pharma Regulatory Affairs

Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

Those working in pharma regulatory affairs jobs not only work in the initial application phase for a new or generic drug, but also in the licensing and marketing stages – making sure all operations and products meet required safety and efficacy standards.

Professionals must combine knowledge of the business, legal and pharmaceutical industries to determine if regulations are being followed and in many cases form the link between pharma companies and regulatory authorities, such as the Food and Drugs Agency (FDA) and the European Union.

Regulatory affairs jobs in the UK and further afield are generally within the pharmaceutical, chemicals,biotechnology, medical devices and cosmetics industries. Organisations such as the FDA, also provide roles for those interested in working in the field.

As biotechnology plays an increasing role within drug development and the pharmaceutical industry, growing numbers of biotech regulatory affairs positions are opening up. Inspection of biotechnology facilities requires a high level of technical knowledge due to the ever advancing systems being used.

Pharma regulatory affairs jobs
Professionals working in pharmaceutical regulatory affairs roles will be required to handle a number of different tasks; from keeping on top of the latest developments within the industry to writing product labels and patent information.

As well as collecting and collating large amounts of information and preparing licensing submissions, pharma regulatory affairs jobs also include liaising with doctors and scientists, conducting clinical trials and negotiating with regulatory authorities.

Workers may also be tasked with undertaking and managing regulatory inspections within the company and reviewing practices when required to meet with new or updated regulatory requirements.

Opportunities for regulatory affairs consultants offer professionals the chance to work in a number of fields, which requires high levels of knowledge of multiple industries.

Jobs in pharma regulatory affairs generally require a background in the applicable industry, business knowledge, great oral and written communication, good attention to detail and strong IT skills.

The international scope of many companies working within the pharmaceutical industry mean that a second language is generally desirable, as it previous work experience within a clinical or pharma setting.

Pharma regulatory affairs jobs in India
Asia has emerged as a strong growth region for the pharmaceutical industry in recent years, in particular India which is fast becoming a preferred location for clinical trials and research and development activities.

The creation of a new product patent system in 2005 was a driver of this growth, which is expected to increase as the domestic market in India further opens up.

This growth has also helped facilitate an increasing number of pharma regulatory affairs jobs in India. A number of companies have set up in the most populous city in the country, creating a number of regulatory affairs jobs in Mumbai.

Figures from a companiesandmarkets.com report show that by the year 2012 the market for clinical trials in India is expected to grow to $630 million (£404 million), helped by the fact that the cost of conducting research in the country is sometimes less than half that in more developed nations.

The United Arab Emirates (UAE) is another country looking to expand its appeal to the pharmaceutical industry, increasing the number of pharma regulatory affairs jobs in Dubai.

A report by RNCOS suggests that compound annual growth of 17 per cent will take place between 2010 and 2013 and that the UAE is ripe for investment for pharmaceutical manufacturing operations.

Regulatory affairs

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas:

• Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
• Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
• Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.^{[citation needed]}

Contents 1 Healthcare RA 1.1 Core competencies 1.2 Origins 1.3 Recent Developments 1.4 Future Developments 1.5 Regulatory Affairs Profession 2 References

Healthcare RA

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

• pharmaceuticals
• medical devices
• in vitro diagnostics
• biologics and biotechnology
• nutritional products
• cosmetics
• veterinary products^{[citation needed]}

The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.^{[citation needed]}

Core competencies

Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor's degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.

Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.

Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.

For more information about the knowledge, skills and abilities of regulatory professionals, read the RAPS white paper, Regulatory Affairs Professional Development Framework: An Overview or see The Regulatory Career Advancement Guide.^{[citation needed]}

Origins

The healthcare industries were the first to be significantly regulated in the modern era. Much of this regulation has stemmed from avoiding the repetition of disasters, and has tended to be led by the USA due to size of the market and its technological lead:^[1]

• Diphtheria Epidemic led to 1902 Biologics Control Act
• Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
• Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
• Thalidomide led to the 1962 Kefauver-Harris Amendments
• Dalkon Shield led to the 1976 Medical Device Amendments
• Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act

In the USA, this regulation is largely written directly into law and codified in Title 21 of the Code of Federal Regulations^[2]

Recent Developments

in 1980 starting (later the European Union) started to harmonize the regulation of healthcare products in the member states.^[3] The concept of regulating medicines was well established in most member countries along similar lines to the US model, but many countries did not have any significant medical device regulation. Concurrently the EU had been developing the concept of [New Approach Directives] where only broad concepts were written into the law and the bulk of the technological detail delegated to compliance with recognized standards (which are more readily update-able).^[4][5][6]

The Europeans took the radical approach of applying the New Approach Directive to Medical Devices and by doing so made the first significant conceptual advance in healthcare regulation for nearly 100 years.

The European Model for medical device has largely been adopted by the Global Harmonization Task Force as the internation template.^[7]

Future Developments

Many in the Regulatory Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety.^[8]

Regulatory Affairs departments are growing within the companies. Due to the changing resources necessary to fulfill the regulatory requirements some companies also choose to outsource or outtask regulatory affairs to external service providers.^[9]

Regulatory Affairs Profession

The (Healthcare) Regulatory Affairs Profession is still an emergent profession but has two major international professional membership societies:

• The Regulatory Affairs Professionals Society, RAPS, http://www.raps.org
• The Organisation for Professionals in Regulatory Affairs, TOPRA, http://www.topra.org

which offer education and training, professional development, competence certification and codes of ethics.^[10][11]

In Canada, the major professional membership society is:

• The Canadian Association of Professional Regulatory Affairs, CAPRA, http://www.capra.ca

Groups related to regulatory affairs issues are active at many social networking websites like LinkedIn and Facebook. FarmavitaR, http://www.farmavitar.net/ ,is managing social networking website dedicated exclusively to regulatory affairs professionals.^[12]

The regulatory professional typically has a background relevant to the business in which they work, i.e., science, medicine, or engineering.

References

1. ^ United States Food and Drug Administration
2. ^ FDA Center for Devices and Radiological Health
3. ^ MeddiQuest Consultants Information Site
4. ^ Medicines and Healthcare Products Regulatory Agency (UK)
5. ^ Europa Medical Devices
6. ^ New Approach Organization
7. ^ Global Harmonization Task Force
8. ^ MeddiQuest: Internation Regulation Consultants Information Pages
9. ^ YES: Your External Support for Regulatory Affairs
10. ^ Regulatory Affairs Professionals Society
11. ^ The Organisation for Professionals in Regulatory Affairs
12. ^ FarmavitaR – Regulatory Affairs Network