More than 50 people came together for this event, to think on a range of key topics and challenges that our industry faces currently. It proved to be a very interactive day with discussions during each presentation, throughout the lunch session and continuing on to the final panel session.
EU PV-Legislation and Guidance
Opening the session Leonardo Ebeling gave his thoughts on some of the risks noted from the EU PV-Legislation and Guidance. He paid particular attention to the fact that the PV processing fees could become un-proportionally elevated for MAHs achieving compliance but suffering from their new or niche products. Of course when these fees affect the Type II Variations, MAHs may have to consider the costs in these decisions, impacting patient safety and penalising the companies. He concluded with some suggestions on how some best practices could allow optimised patient safety.
Rune Ringsholm Bergendorff kicked off the hot topic of the ongoing ISO IDMP implementation. Although IDMP is driven by the PV regulations, we start by realising that PV holds very little of the information required to fulfil the requirements. He went on to describe the various stakeholders from the regulators themselves to Manufacturing, Regulatory, IT, Clinical, PV etc. and detailed how all of their associated systems were historically very much siloed within organisations. As the EMA works towards implementation of IDMP through the SPOR roadmap initiatives to drive towards convergence, so MAH should be trending towards common data hubs. He ended with a discussion on where the links are between ISO IDMP and ISO ICSRs (R3).
After the coffee break Thorsten Frank Jørgensen, Medicine Inspector DHMA, shared his thoughts on audits and inspections. He raised some interesting findings from recent inspections including a range of issues with ICSR distribution (under reporting, over reporting and erroneous reporting). He mentioned that many contracts related to study conduct do not include the critical piece of “safety information exchange” or timelines for exchange of information. Therefore people aren’t doing this properly. Providing people with the ability to give transparency on compliance, ideally through automated software tools would be a huge benefit.
Jeffrey Ho from Navitas Life Sciences then gave a really interesting talk around risk identification in general, with a focus on affiliate PV activities. He shared his insights on benchmarking and provided a fascinating approach for visual risk identification and assessment. With many representatives from affiliates present for this talk it certainly sparked a lot of discussion. With the increasing scrutiny on pharmaceutical companies’ oversight of their global PV systems, many are shifting toward more centralised organisational models where possible. Despite this, the fact remains that affiliates still play a crucial role in key processes from ICSR processing and submission to label updates and therefore, continue to play a critical role in achieving compliance, operational success, and regulatory intelligence. This talk explored common affiliate models, ways of assessing the effectiveness of these models, and approaches used to address common challenges.
Betina Østergaard Eriksen, the deputy QPPV from Novo Nordisk, discussed the PV regulatory expectations (GVP module II, GVP module VI rev1 and abpi guidelines) for Patient Support Programmes (PSPs) and Market Research Programmes (MRPs) and how although the regulations are very vague they are leading to big regulatory inspection findings. Following on from this she suggested a few practical mitigations that can be employed to ensure all planned programmes can be identified as PSPs or MRPs by developing an SOPs and using a decision tree to identify them, ensuring adequate SDEAs are in place and the PVQP has oversight. She finished by stressing to ensure that vendors are qualified, that there is a process for reconciliation of events and a process for source data verification.
PV and Scientific Literature Searching
Daan De Jong from Elsevier provided the final talk of the day on the topic of PV and scientific literature searching. This was a great end to the day, discussing best practices for saving time, staying current and mitigating risk in the face of the increasingly complex and changing processes in literature monitoring. The background to this is that with an increasing volume of unstructured content to cover, along with rising labour costs, pharmaceutical manufacturers are looking for ways to make their literature monitoring more effective and efficient. Adding to the complexity, EMA will in-source literature monitoring for 300 active chemical substance groups (generics) and 100 herbal substance groups, beginning in September 2015.
Many people stayed on for the active panel discussions which concluded a very informative day.