Front left to right: Dan Wygal, Laragh de Bhulbh, Caroline Kelly, Rachael Orme-Smith, Sarah O'Neil
Rear left to right: Hugh Adams, Lucy Tobin, Vlad Maystr, Oliver O'Connor, Eavan Daly
On 10th May, we were delighted to be able to come together in person and remotely for our annual Pharma Integrity Conference themed this year as "Evolution and Opportunity in Ireland". Our experienced panel of speakers embraced the theme throughout the day from both an operational standpoint on driving industry best practice through culture to a more practical implementation of best practice on a daily basis. There was a fantastic attendance on the day with delegate feedback focusing on the high quality of the talks and how relevant the topics were.
The day started with talks from Sarah O’Neill, Chair of the Regulatory Sub-Committee of Medicines for Ireland (MfI) and Oliver O’Connor, Chief Executive of IPHA. Both impressed the importance of reputation within the industry. Sarah discussed how MfI work closely with the HPRA and have just updated the MfI Code of Practice with increased focus on its scope, hospitality arrangements, scientific services, digital and virtual channels and complaints management, among other topics. Oliver discussed IPHA's work on Irish medicines verification, how Brexit was a turning point for Industry working with Government, and how transparency continues to be of utmost importance in how we present ourselves as an industry.
Dan Wygal, Country President of AstraZeneca spoke about how their company values build and go beyond the European and Irish Regulations, as well as industry codes of practice to drive best practice in all that they do. AstraZeneca is a values-led company, and are evolving to be nimble and flexible, which is a must with the volume of science both from clinical trials and real-world evidence that is being generated today. The session covered how it is critical that the data companies have is understood externally and that companies should be seen as a thought partner driving disease awareness. Dan spoke about the importance internally of doing the right thing and having a culture that is open and transparent. He spoke about the opportunity that arises within organisations by creating SOPs that are relatable, employing third parties to deliver training so there is an objective voice involved, and how AstraZeneca use this approach as they constantly strive to exceed expectations.
The patient’s voice was represented by IPPOSI Chief Executive Derick Mitchell whose call to action for the Pharma Industry was to engage openly with patient organisations, look for ways to collaborate and to promote mutual learning opportunities that extend beyond just disease awareness activities. He encouraged companies to be more courageous and imaginative in how they work with patient organisations, and stressed the importance of continuous cross functional feedback within companies on the disproportionate burden of expectation that companies often impose on patient organisations in terms of contractual arrangements. He spoke of the evolution of patients being viewed to be experts and disease area KOLs in their own right. The key themes were educate, involve, and impact.
Pharma Integrity Managing Director Caroline Kelly focused on ensuring clarity and considering risk. Caroline spoke about the current legislative enforcement in Ireland and ensuring clarity in all approaches to materials – the importance of understanding what you are trying to achieve from the outset when creating material and how that subsequently appears to key stakeholders. Clarity internally makes it much easier for clarity externally. This session also covered operational aspects of fulfilling legislative and Code requirements for all materials, be they full advertisements, reminder advertisements or patient information. Another consideration was the legibility of prescribing information and the impact layout and formatting has (for more information on this topic see our blog post here). Caroline also discussed the purpose of MAH inspections and examples of triggers, as well as how to prepare for them. Pharma Integrity provide support with MAH inspection readiness assessments, contact us for more details.
The increased focus on digital engagement which has been accelerated by the Covid-19 pandemic was covered by Hugh Adams and Rachel Orme-Smith from Astellas in their session on “The Dynamics of Digital: Creating Agility & Confidence”. Key take-aways for delegates included considerations such as what content-creators consider vs. compliance reviewers during material creation, and the importance of having medical integrated in the creation process and not leaving the compliance responsibilities to the third party agency creating your materials.
The evolution and opportunities for medical affairs in Ireland was covered by Laragh de Bhulbh, Pharma Integrity. Laragh spoke about how medical affairs has evolved from a more traditional support function to an integrated cross-functional partner that brings value throughout the lifecycle of the medicine through pro-active engagement. The opportunities for medical exist in knowing your audience, having a clear strategy for your plan and measuring the impact of tactics, and using the insights gathered in-field to constantly adapt to ensure the gaps in the patient journey are addressed.
Eavan Daly, the Medical Director for GSK led an interactive session on operational best practices when conducting advisory boards involving Irish experts. The emphasis was on identifying if there is a legitimate need for advice, and clearly documenting internally the rationale and intent for the advisory board. By clearly defining the rationale at the beginning scope creep is prevented, and any potential risks arising from this. Eavan also emphasised the importance of tracking all actions subsequent to an advisory board so that it is clear what has been achieved.
In the session Licence to Operate: achieving quality in practice run by Pharma Integrity’s Lucy Tobin, the audience were encouraged to consider the end user in the development of a quality framework. Lucy covered in detail what an effective Quality Management System looked like through considerations for SOPs, the importance of checklists and template documents, and what effective monitoring and internal auditing is. Lucy provided clear examples including the importance of a risk matrix in the management of non-GxP deviations. Pharma Integrity have a suite of checklists and template documents available for purchase, contact us to learn more.
The last talk of the day was from Vlad Maystr one of Veeva's Customer Success Managers who provided helpful and useful tips on how to maximise the potential of PromoMats. There were many useful nuggets of information on how to enhance material creation and review.
The main themes running through the day were the importance of culture, planning, effective record keeping and open communication, and the benefit this brings both internally and externally. As well as the high quality of the talks delegates noted that the talks had high cross-functional relevance and many said they would encourage their colleagues in different areas to attend future meetings. We will share details of our plans for Conference 2023 at the end of the year!