23rd October 2016

On Thursday 20th October I visited the UK Bioscience Forum at the Royal College of Surgeons in London. This was a fascinating event with attendance from the UK bioscience research sector (both academic and commercial) as well as  charities and the National Health Service and Public Health England.

Whilst pharmacovigilance and risk management was not necessarily at the forefront of peoples minds, as many of the products are a very early stages of development, I did have some good conversations. Many of these products will have very targeted populations making the benefit-risk decision making rather complex, and the integration of the patient perspective becomes more important.

The event was wide ranging with talks looking at the state of the bio-science industry in the UK, issues surrounding anti-microbial resistance and advances in devices and therapeutics for Type 1 diabetes. The final talk of the day, almost inevitably, was the potential impact of Brexit. The complexity of the upcoming negotiations will have an impact on all of us – whether we live in the UK, the EU, or elsewhere.

 

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11th October 2016

The 3rd Pharmacovigilance and Risk Management summit in Vienna (28th and 29th September) is only 10 days ago, but seems much longer.

The conference was full of interesting and thought provoking talks, many of which highlighted the strides that pharmacovigilance has made over the past few years; moving from a peripheral to central part of company strategy.

Now that ICH M4E(R2) has reached step 4 and will be reaching step 5 over the next months, there is even more reason for PV to be central to strategy early in development as the benefit-risk profile of medicines becomes defined and the specific needs for eveidence generation for a successful filing strategy become clear.

Whilst that note was definitely optimistic, there was also a general concern at the levels of workload and in particular the potential for divergence rather than harmonisation in regulatory guidances, even where they all link to the same overarching ICH guidance.

My blog picture this week is taken from the EU-PROTECT benefit-risk website which is an amazing resource for those of us looking to better develop material that communicates benefit-risk well (http://protectbenefitrisk.eu/)