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Sharon Leighton Consultancy        
           February 2013
 

Greetings!

 

February is an "funny" month in the corporate calendar.  Hopefully you've done all the 2012 annual reviews, written up multiple appraisals and finalised 2013 objectives.  
 
So it can seem like the year is starting now.  Maybe you're looking for basic or advanced Medical Affairs training that focuses on Europe-wide aspects, not just the UK.  Maybe your team need to sharpen their writing skills. If so, I'm offering 3 open courses during April, May & June:
  • European Medical Affairs: Consolidating the Basics. April 30th, Central London
  • European Medical Affairs: Beyond the Basics. May 1st Central London
  • Smarter Writing - Medical Information Responses.  June (date to be agreed), Central London
If you want to know more or book, check out my training website . I usually run these courses for my clients so this is a great opportunity for someone to learn from others working for different companies and countries.

I'm also excited about the first residential course I'm helping to run this weekend on Coping with Corporate Life - a Mindfulness Approach.  If you'd like to experience a taster session with others working in Medical Information or Pharmacovigilance on Mindfulness in London on May 17th, let me know .
 
Sharon 
Highlights from this issue
EU Medical Affairs Training
New guidance on UK data protection in pharmacovigilance
The automation of systematic reviews
Review of the shortcomings of product information for medicines
How to prepare and review a summary of product characteristics
NICE - guidance on developing local formularies
NHS patient data and clinical research - coming together at last?
Google's New Drug Search Result Format
Udinie - Articles on anything
Interesting Times Ahead for Intranet Managers
European adoption of physician-only social networks growing
Article Headline
10 Ways to activate digital opinion leaders
Creation Pinpoint. Social media monitoring tool for studying healthcare professional conversations
Managing your online reputation - guide for HCPs
European Medical Affairs - Your Essential Toolkit. April 30th - May 1st 2013, Central London

This 2 day course is ideal for anyone working in Medical Affairs/Medical Information who needs to enhance their basic skills or develop advanced Medical Affairs/Medical Information skills
  • Consolidate the Basics (regulations, finding the best clinical evidence, evaluating information, handling queries and writing clear English)
  • Beyond the Basics (Inspection readiness, evaluating your services, metrics, showing your value, partnerships with sales and marketing, managing change)
New guidance on UK data protection in pharmacovigilance  

Joint ABPI & PIPA guidance on data protection issues in post marketing situations.

The pharmacovigilance process can bring many challenges in ensuring patients' personal data is held and transmitted in line with data protection legislation.

The automation of systematic reviews
 
Cochrane systematic reviews created by machines? Still a dream but is this plausible?

This BMJ article talks about the possibility of automating systematic reviews as they need checking and possibly updating every 2 years.  In practice, it may take as much time to update a review as it did to produce the original review.  Since we effectively write a systematic review as our Medical Information responses, could this be automated too?

Read more ...
Review of the shortcomings of product information for
medicines
- UK Government view MHRA

 MHRA response to EU proposals to improve product information for doctors & patients. Timely, balanced, targeted & quality info needed

The new Pharmacovigilance Directive [Council Directive 2010/84/EC] requires the European Commission (EC) to produce a report on the shortcomings of product information and to bring forward proposals for legislative change.

How to prepare and review a summary of product characteristics

EMA guidance on preparing & reviewing the SmPC

The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. It is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the Agency as part of applications for new marketing authorisations or updates to existing marketing authorisations.

NICE produces guidance on developing a local formulary

Also interim statement on how they develop good practice guidance 

The guidance, produced by NICE (National Institute for Health and Clinical Excellence), is first in a series of guidance on handling, prescribing, commissioning and decision making about medicines.  There hasn't been a standard process for putting together a local formulary to consider medicines that are not already covered in NICE guidelines.

NHS patient data and clinical research - coming together at last?

Opportunities for real-world data in UK NHS data CPRD databank - lovely commentary by Les Rose.

In the mid-1990s, an NHS teaching hospital close to my offices invited proposals for expanding its clinical trials unit. Hitherto it had operated a small Phase I unit with a few beds, and the idea was to develop that into a major early phase facility, and also to diversify into later phase work, with commercial sponsorship high on the agenda.

Google's New Drug Search Result Format

John Mack's (aka Pharmaguy) backgrounder of Google Knowledge Graph to find medicines info & lack of pharma role.

In June 2010 Google launched a new drug search result format that includes everything FDA requires that a drug company include in its direct to consumer advertising: fair balance, and direct links to side effects, precautions, dietary information, etc. It even included a pill icon that identified it as sanctioned by a trusted authority!

Read more ...
Udinie - Articles on anything.

For those of us without our own library service Udini sounds very useful!

 

Udini is the world's article store for entrepreneurs, consultants, educators and everyone else who needs quality research.    

 

Read more ... 

Interesting Times Ahead for Intranet Managers

For all you folks who help run or use intranets, neat article from Freepint. The times they are a changin'

 

Over the last few months FreePint has published a wide array of articles on the subject of intranets. James Mullan identifies the key trends in the editorials, from collaboration to content creation, big data and findability. He highlights some of the articles which discuss implementation and best practice in use of collaborative tools and, finally, he ponders which tool will be the "big thing" for intranets in 2013.

 

European adoption of physician-only social networks growing

EU docs *do* want to interact with pharma on their closed physician peer2peer networks: their most requested feature!

European doctors' use of closed social networks showed a marked increase last year, with adoption up from 13 per cent in 2011 to 22 per cent, according to Manhattan Research.

Read more ...
The digital dilemma for pharma in Turkey

The digital dilemma for healthcare companies in Turkey.

It's taking time here in Turkey for pharma to have confidence in the crop of new, digitally-savvy agencies. We still have a pretty strong divide between those with digital skills and the healthcare communications specialists.  

 

10 Ways to activate digital opinion leaders

Having worked on KOL identification projects using web 2.0 tools myself, nice article from Daniel Ghinn on digital KOL tools.

Research indicates that a tipping point has been reached for healthcare professionals (HCPs) using public social media channels to discuss clinical and practice matters with their peers.

Read more ...
Creation Pinpoint. Social media monitoring tool for studying healthcare professional conversations.

Great work from Creation Healthcare, as always. Home to Daniel Ghinn & Paul Grant, who've talked about social media to Med Info folks at DIA EU Medical Information & Communications conferences

 

Creation Pinpoint is the world's only social media monitoring tool dedicated to studying conversations taking place between healthcare professionals.  

 

Establishing, Managing, and Protecting Your Online Reputation: A Social Media Guide for Physicians and Medical Practices

How to manage your online reputation as a doctor or healthcare provider from the legendary Kevin MD

Online health information combined with social media channels like Twitter and Facebook has created a new generation of patients. They are empowered. They have a voice in their own care that they never had before. And more are using social media and physician review sites to choose their doctor or medical practice.

Read more ...
Technology trends facing pharma in 2013

As techie junkies Med Info people love apps, tools and innovation - anything here catch your eye?

Pharmaceutical companies and other players in the life sciences industry need to get to grips with new and potentially disruptive technologies to help them emerge from a challenging operating environment, says a new report.

Cross-Culture Communication: Collaborative Efforts a Must!

Just 2 weeks to the DIA US Med Comms meeting! I'm chairing the Globalisation session so this looks a great reference!

It's no secret that today's workplace is rapidly becoming vast, as the business environment expands to include various geographic locations and span numerous cultures. What can be difficult, however, is understanding how to communicate effectively with individuals who speak another language, or who rely on different means to reach a common goal.

Read more ...

Did you know I have a Facebook page?

 

It's the easiest way for me to update people to great links, interesting articles or blogs, compelling news and the occasional fun stuff.   

Take a look!

Or check out LinkedIn and Twitter (@SharonLeighton).... 


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SharonWho am I?

After leaving corporate life 7 years ago, I set up my own Medical Affairs consultancy and training business, believing that there wasn't much demand for either service.  Luckily, I proved myself wrong and now have a long client list from many large and small pharmaceutical companies.  I'm passionate about my business, Medical Information, social media, information to patients and all things geek.


I help busy managers succeed in their goals by
  • managing projects  
  • training their staff on MI practice and leadership
  • mentoring managers new to Medical Information or Medical Affairs
  • helping them restructure their business 

And now we build tools to monitor your customer's perceptions of your service.  You name it, I can probably do it.

 

Contact Information
phone   +44 7545 972727 (plus FaceTime and iMessage) 

email    sharon@sharonleighton.co.uk

Blog  www.sharonleighton.co.uk/news 

Twitter   SharonLeighton