https://mhrainspectorate.blog.gov.uk/2017/03/03/mhra-gdp-symposium-2016/

MHRA GDP Symposium 2016

I am Bernadette Wilson a GDP Inspector who assisted with the organisation of the MHRA GMDP 2016 Symposium.  I took to the stage for the first time this year to present on the topic of whistleblowing.  I am pleased to share the highlights of this well received event.

The Symposium 2016 made use of the new MHRA event app for smartphones and other devices this year.  This was used for delegates to participate in the interactive sessions and to access information associated with the event from their own devices. We aimed to enhance stakeholder engagement throughout the event and this has been well received.

As usual, the London event sold out very quickly and a large number of delegates chose to attend the event in Glasgow.

The GDP days covered a varied range of what were considered poignant and current topics.

An exploration of company culture highlighting the way individuals interact, use processes and the effect that this has on compliance was the main theme running throughout the day.

Senior GDP Inspector Tony Orme and GDP Inspector Gaynor Brummitt advised delegates about the interactions of the MHRA and GDP Inspectors with internal and external stakeholders.

Falsified Medicines Directive

Delegates were keen to hear from Senior GDP Inspector Peter Blundell about the up-coming changes and impact of the Falsified Medicines Directive (FMD). The implementation of the safety features is designed to deliver the full benefits of the FMD whilst minimising the burden throughout the medicines supply chain.

To support its implementation, the UK have established a cross agency Implementation Advisory Board with representatives from across the supply chain including professional bodies, public bodies and industry.  It has been supported by individual task and finish groups on specific subjects such as

  • Wholesalers / flexibilities
  • Healthcare Institutions
  • Pharmacy
  • System providers / Coding

The Board will report its recommendations to the national competent authorities and advise the UK Government.

Whistleblowing and Enforcement

Naseem Hudroge, MHRA Intelligence Analyst, joined the day from the MHRA Enforcement section to highlight the challenges the team are currently facing in relation to maintaining the legitimate supply chain and the movement of controlled medicinal products, particularly Zopiclone, Nitrazepam, Diazepam and Zolpidem.

My whistleblowing presentation highlighted the obligations placed on the Wholesaler to immediately inform the Competent Authority or the Marketing Authorisation Holder of any medicinal products they identify as falsified or suspect to be falsified, and the procedures available for reporting wrongdoing to the MHRA.

Error chains

Senior GDP Inspector Cheryl Blake and GDP Inspector Terry Madigan closed the morning session with their presentation and interactive scenarios on error chains.

Error Chain = Assembly of contributory factors that may not individually cause an error but together lead to one occurring

The scenarios gave the delegates the opportunity to interact with each other and to test their own knowledge and experiences to reach the answers.

Networks and inspectors surgeries

The scheduled breaks also gave the delegates the opportunity to speak directly and informally with inspectors and ask questions during the ‘inspectors surgeries’.  Those who did not get the chance to meet with an inspector still had the opportunity to submit questions on-line which were displayed on the large screens throughout the day.  Any additional questions are reviewed by the team and the answers posted to the delegate area of the event app.

DMRC update

Sandra Bax, The Defective Medicines Reporting Centre Manager opened the afternoon session to inform delegates of the role of the MHRA Defective Medicines centre and detail the processes involved in the recall of medicinal products.

Company factors

The topic of Company Factors and the Impacts on GDP Compliance was presented by GDP Operations Manager Phil Neale and Senior GDP Inspector Madeleine Ault.  The aim of the presentation was to encourage delegates to think about what factors might influence GDP compliance within their own companies.

Their closing message was;

If you want to be really good then pay attention to the impact organisational culture has on your GDP operations.

Aim to develop appropriate cultures.

Finally a quiz

The day concluded with a quiz which enabled delegates to utilize the event app and to test their knowledge and learning points from the day and their understanding of licensing requirements.

With GDP being such a vast and varied business to operate within, the aim was to include something for everyone.

Overall

The Inspectors enjoyed the opportunity of meeting with the delegates and were pleased to welcome regular delegates back as well as those attending for the first time. We have received a substantial number of positive comments and feedback.  We are pleased that you found the event useful and interesting.  For those who have ideas about how we can improve the content for 2017, please let us know.  Your feedback is very important to us.  It is only with your input that we can create the symposium that you want.

A huge thank you to all of you who attended, to the presenters and organisers, the events management team, Glasgows and our own Communications department – all of whom who contributed to making the event such a success.  We are already looking forward to welcoming you all to the 2017 event.


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