Alison Wilson from Almac (pictured below) looked at the role of pharmacokinetics to aid pharmaceutical development (data integrity, alcohol effects and In Vitro In Vivo Correlations). One of the issues that Alison spoke about at length was ‘dose dumping’ – unintended, rapid drug release in a short period of time of the entire amount or a significant fraction of the drug contained in a modified release dosage form. Over the course of her presentation, Alison gave examples of how PK plays a pivotal role in managing drug development and the role that PK plays within Almac.
Successful Irish life science entrepreneur Mary Burke spoke about Bioanalytical Method Validation from an FDA and EMA perspective. ICH M10 formed a major part in Mary’s excellent overview and she touched upon the ‘grey areas’ thrown out by ICH M10 such as Commercial Kits, Endogenous Compounds and Dried Matrix Methods. The draft guidance for ICH M10 is currently available and the EMA have committed to providing feedback on the issue by early September of 2019.
Anne Hayes of the HPRA was a speaker at the 2018 event and returned this year to look at the issue of EU safety features for pack integrity and authenticity. Anne, an inspector at Ireland’s national authority, played a significant role in the European development of the Falsified Medicines Directive and as such, there was considerable interest in her presentation. During her presentation she looked at two main areas: supply chain and safety features. The role of the IMVO in Ireland and the EMVO as a European body drew a number of questions from delegates eager to better understand the role that these medicine verification organisations (and their other European counterparts) are undertaking.
Patricia Pengelly from AbbVie looked at the latest trends in pharmacovigilance. The increased rate of adverse event reporting, product complexity, the interface between tech and PV, and concerns around safety and transparency all featured in the presentation. In particular, Patricia highlighted the development of PV within the African nations over the past twenty years. Within that time period, there has been a considerable development of PV and legal requirements for medicinal products. Patricia also touched upon the interaction between the PV function and the quality function within a business.
The final speaker on the day was Pat Lennon from Roche Ireland. Pat’s insightful presentation looked at how the firm has managed its GDPR obligations within the past year. As Compliance Officer within Roche Ireland, Pat outlined the complexity of managing data privacy issues and the issues surrounding transparency within the pharmaceutical sector.
The RQA‘s Irish conference has a track record for introducing delegates to speakers with real industry experience and it aims to give delegates tangible lessons that they can apply in their own companies. The 2019 event, as in other years, did not fail in that respect.
Acorn Regulatory were delighted to be involved as main sponsors and we look forward to continuing to work with the Irish chapter on future events.
If you would like further information on the RQA then you can click here.
If you would like to discuss issues relating to pack safety features, pharmacovigilance, regulatory affairs or another issue then please contact us on 00353 52 61 76 706 or complete the webform below.
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