Editor’s Voice: July – pharma safety and pharmacovigilance roundup

Take a look at some of the safety and pharmacovigilance content published on pharmaphorum this month, as well as our new whitepapers and a look towards what’s coming up in August’s mobile health focus.

July has been one exciting month for us Brits – from an unexpected heatwave (that’s managed to last a few weeks so far) to the arrival of a new Royal Baby that’s had the world gripped.

There’s also been a lot going on here at pharmaphorum. July has been our discipline focus on safety and pharmacovigilance – a hot topic around the world, not just for the pharma industry itself, but also for healthcare professionals and patients.

It’s vital that the safety and efficacy of every medicine is monitored closely and therefore one of the biggest challenges is keeping up with the ever-evolving regulations. This issue was explored in an article by Marc Pignot, Christian Schübel, Alfred Pauls and Klaas Heinemann who provided us with an update on the new medical device regulations in the EU and how they will impact medical device safety and vigilance.

Meanwhile, PRA International’s Tarun Pandotra shared his insights into the safety and pharmacovigilance strategies in the emerging markets, and more specifically, India.

Plus, Derek Woodcock from CrossOak Pharma Ltd gave us an overview of the Pharmacovigilance System Master File – a requirement that’s been in place since July 2012.

“It’s vital that the safety and efficacy of every medicine is monitored closely…”

And in an interview with Amgen‘s Vice President of Global Regulatory Affairs and Safety, Alan Morrison, we found out first-hand how pharma tackles safety and pharmacovigilance.

Regulations aren’t the only challenge, however. Evaluating the safety of new cancer treatments in early phase research is a complex business, says Cancer Research UK’s Jabeen Ahmed.

Also, another article that should not be missed this month is one from Cutting Edge Research’s Sarah Ray, who compared the drug safety methods of pharma, including how to use social media to track adverse events, with the well-known TV show, Game of Thrones.

Our disease focus this month has been on musculoskeletal disorders. Simon-Kucher & Partners’ Kristina Harter discussed her thoughts on how the future rheumatoid arthritis market will be dominated by how innovative orals and biosimilars interact with existing stakeholders. While BioClinica’s Colin Miller explored how the increasing FDA examinations of therapies used to treat type 2 diabetes mellitus (T2DM) are leading to a rise in bone safety studies prior to approval and how this means that clinicians are turning to Quantitative Computed Tomography (QCT).

Have you seen pharmaphorum’s new whitepapers?

Make sure you don’t miss our whitepaper section on pharmaphorum. In July, we’ve published three brand new whitepapers that are definitely worth a read:

• In “Maximising pharma launch success in challenging times“, CSD presents the results of its recent survey of pharma marketers exploring the challenges faced when planning a new product launch, as well as looking at some common themes around market access and integration.

• MXM Health highlights how to effectively engage in the rare disease space, looking at the challenges and skill-based solutions for training sales forces in this field.


“In July, we’ve published three brand new whitepapers that are definitely worth a read…”


• Understanding drug use beyond the clinical trial setting is critical for success, discusses Kantar Health in its whitepaper, “Understanding patient outcomes in the real world”, by comparing the opinions from attendees at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 18th Annual International Meeting with actual patient-reported data from its National Health and Wellness Survey (NHWS).

What else has pharmaphorum published in July?

Other content worth checking out this month includes:

• PhRMA’s John J. Castellani explored the potential of novel cardiovascular disease treatments currently under development in “Getting to the heart of the matter: medicines save lives and money“.

• Daniel Ghinn’s latest Pharma gets social article, which looked at how pharma uses social media to engage oncologists at the annual ASCO 2013 conference.

• pharmaphorum’s Rebecca Aris interviewed digital health expert Paul Sonnier, for her latest Digital Health Perspectives. Paul is the Head of Digital Health Strategy at Popper & Company and founder of the Digital Health LinkedIn group, which currently boasts over 18,000 members.

• In “It’s not you, it’s me…“, Stephen I’Anson, from Drugs in Context, discussed the statistic that over two-thirds of respondents in a recent survey reported that they have had an article rejected from a journal.


“August sees the return of our popular mobile health focus month…”


• Pharmalot’s Ed Silverman shared his opinions on the GlaxoSmithKline bribery scandal in China in “Pharma news highlights: GSK, Merck and the FDA.

• Eli Lilly and Company’s Amy Sousa provided a first-person account of her recent volunteering experience in South Africa, where she conducted diabetes health screenings and gave support to patients.

What’s on the agenda for August?

August sees the return of our popular mobile health focus month, with articles comparing the rise in digital technology and mhealth apps to superheroes, how apps are being used to transform surgery (think the board game ‘Operation’) to a piece about how the Quantified Self Movement may not always be the answer.

So make sure you keep an eye out during the next few weeks! In the meantime, we hope you continue to enjoy pharmaphorum and our content. As always, we appreciate any feedback you may have, so if you have any suggestions on how we can further improve, please email us directly through our online contact form.


About the author:

Hannah joined pharmaphorum in early 2012, after graduating with a degree in Magazine Journalism & Feature Writing in 2011, and leads our news coverage, in addition to liaising with new and existing feature authors. With over three years’ experience working within the journalism industry alongside university, Hannah has written for a number of different print and online publications, within the women’s lifestyle, travel and celebrity sectors. Now focussed on the pharma sector with her role at pharmaphorum, Hannah is embracing the challenges of working within a fast growing media organisation in this rapidly changing industry sector.

For any queries or contribution suggestions, please contact her here or via Twitter @Hannah_Blake2.

How do safety and pharmacovigilance strategies differ around the world?