Two seminar days, 12 in-depth topics, 25 speakers, 140 visitors. These numbers of the second edition of the European Pharmacovigilance Congress 2018. We have pointed out the concepts that we consider most interesting for our readers.

1. Updates of Eudravigilance and knowledge gained in a year of implementation of the new rules

Calin Lungu, EudraVigilance and XEVMPD Trainer form EMA and CEO of DDCS, has listed some practical advice for the case management emerged from the first session. One above all: it is good to set a download date that includes the three days before the last available data. It is an action that preserves from the download of duplicates and saves by downloading a case with an error that it will be correct the next day.
Calin has also clarified that the day zero – this is how the data of start for data exchange deadlines is defined – is a concept not recognized by EMA, but an object of an agreement that pharmaceutical companies define with an internal standard operating procedure (SOP) and agree with the partners (SDEA – Security Data Exchange Agreement).

Françoise Dumas Sillan, Vice President and Head of the Global QPPV Office of Pfizer, participant in the pilot phase, has reached the number of cases downloaded by the company: 18 thousand a month. Of these, as many as 65% are invalid. She also described – with critical tones – the slowness of the resolution of some technical problems of the Eudraviglilance software.

Paolo Porcelli, Senior Inspector GVP and AIFA Inspection and Certification Office, provided the data emerged from the inspections. Signal detection was the most critical area. On the increase the findings on the computer systems for pharmacovigilance in particular on the database quality, data missing, validation and lack of comparisons on download and transmission compared to the paper.

2. Signal management

Speakers at the session dedicated to the signal detection were Glyn Belcher, expert in Signal Detection and Risk Management at PV Consultancy Ltd and Mircea Ciuca, Global Head Medical and Clinical Drug Safety at Vifor Pharma, eRMR.

The first one has provided some suggestions to optimize the signal analysis, such as, for example, adjusting the frequency to the volume of the monthly cases received: companies with more than 30 ICSRs should perform it monthly, while those who register less can do it every 3/6 months. He also underlined the importance of communication between the various actors involved in pharmacovigilance, that is among experts of case processing, of risk management and of signal detection.
A warm recommendation is that not to use the disporportionality indicators, useful for statistical analysis, as absolute truth, but also to always perform the manual review of the individual case for the qualitative evaluation.

The second has made an excursus on the commitments of the MAH according to the GVP, remembering, for example, the obligation to access Eudravigilance, to invest in dedicated staff to signal management appropriately trained and to adapt SDEA and internal procedures to the new requirements.

3. Pharmacovigilance quality system and impacts of the new Eudravigilance requirements

In this session Françoise Dumas Sillan, Vice President, Head Global QPPV office of Pfizer, defined the role, the tasks and the responsibilities of the figure of the QPPV, defining it as the main contact for any Regulatory Agency to guarantee the quality and efficiency of the company pharmacovigilance processes and of the risk monitoring and management. The requirements of EU QPPVs should be compliant with those of global QPPVs, as more and more countries outside the EU require MAHs to nominate a locally active QPPV and some extra EU countries have integrated EU GVP requirements with those of their own guidelines.
While the EU QPPV has no legal responsibilities outside the European territories, its role is globalized to support regional and national QPPVs around the world, ensuring compliance with their local requirements. This is achieved through the activities of the QPPV Councils coordinated by the QPPV Compliance Office.

Jorgen Matz, Head of Global Pharmacovigilance and Drug Safety of InsudPharma, spoke about the Pharmacovigilance System Master File describing the objectives and listing the main challenges, such as, for example, the lack of clarity in the description of the QPPV responsibilities and delegations (Annex A), in the description of the organizational structure and in the audit approach and all all that goes with it. However, those involving higher non-compliance relate, however, to relations that take place outside the EU, in primis the exhaustive description of contractual agreements with partners.

In conclusion Jose Alberto Ayala Ortiz, CEO of PVpharm, EU QPPV and trainer of EudraVigilance EVWeb-XEVMPD, gave an overview of the fundamental points of the Quality System and of the steps that the MAHs must put in place to achieve it. He also highlighted the changes that took place on 22 November 2017 and the uncertain points, that are the implementation of the ISO IDMP WHO and the definition of post-Brexit agreements.

4. Brexit and the pharmacovigilance impacts

Glyn Belcher has also made an intervention regarding the Brexit, by saying that the exit of Great Britain from Europe, in addition to the climate of uncertainty, will bring many problems, one of them related to the relocation of the EMA headquarters that could cause inconvenience and delays in processes.
In addition, EU QPPVs will no longer be able to reside in the United Kingdom, which, in turn, requires that their QPPVs reside within national borders. Another issue concerns the marketing authorizations because the centrally approved drugs will have to have a specific marketing authorization for the British market, as well as the companies will have to have branch offices and contact person in the UK.
He pointed out that inspections and findings from the United Kingdom will no longer be accepted in Europe. However, there will be a transition period that will last until the end of 2020, the date of effective exit from Europe, during which the regulations and the pharmacovigilance processes will remain unchanged.

5. Ethics in pharmacovigilance

Pharmacovigilance has public welfare as its final goal. It aims to maximize social well-being, balancing individual freedoms with positive results for public health, and affects social justice, promoting good health for everyone and limiting unjust inequalities.
These are the affirmations of Damon Green, Medical Safety Surveillance Officer of Emergent BioSolutions and Former Medical Officer at FDA (CBER and CDER), which originated the need to deepen the concept; asked if the increased access of patients to information has increased their safety, he replied that he has actually complicated things: patients suffer the influence of advertising that promotes more the benefits of a drug, than the possible risks that are instead cited too quickly. Patients therefore do not fully perceive them and project very high expectations onto the drug.

6. Patient Support Programs

Phillipp Eichorn, Senior Director and Worldwide Safety and Regulatory of Pfizer, explained in detail what a Patient Support Program (PSP) and a Market Research Program (MRP) are, by defining, on the basis of Module VI of the GVPs, the first one as an organized system in which the MAH receives and collects information on the use of its medicinal products and the second one as a program for collecting, recording and analyzing data relevant to marketing and business development of a drug (for example a survey to understand why patients switch to a competing drug). These data collections are useful, in addition to the purpose, also to make a signal evaluation even more accurate. It is always good to be careful about under or over-reporting that could add “noise” to the safety database.

Raquel Martinez, Manager and EMEA Pharmacovigilance Agreements of Baxter S.L, instead, advised to detail the most minutely contracts and agreements with third parties that carry out PSP and/or MRP activities. In fact, some common findings during inspections on PSP and MRP are related to an absence or an inappropriateness of the agreements regarding adverse events collection, a deficit in the reconciliation process and a MAH failure of monitoring and audit of vendor running the PSP/MRP. It is also recommended to do more in-depth training for all the people involved, both within the company and within the supplier’s organization.

7. Advanced therapies

That of the advanced therapies is an important topic that has been touched by David Chonzi, Vice President and Head of Patient Safety and Pharmacovigilance of Kite Pharma, bringing the example of Chirmeric Antigen Receptor (CAR) T cell therapy, a new immunotherapeutic approach that implies the engineering of the patient’s immune cells. Certain risks have been identified since the therapy and are now under surveillance. For this purpose, postmarketing registers have been set up in USA and EU to record all the data on safety and risk minimization on patients who must be followed for a minimum of 15 years.

8. Risk management and minimization

There were 4 the speakers of this session: Doris Irene Stenver, Chief Medical Officer of the Danish Medicines Agency and member of the Pharmacovigilance Risk Assessment Committee (PRAC) and EMA; Glyn Belcher; Fabio de Gregorio, Vice President, Head of Drug Safety Europe and EU QPPV of Shionogi; Gian Nicola Castiglione, Director Global Pharmacovigilance and EU QPPV of Chiesi Farmaceutici S.p.A ..
They informed the audience about the activities of PRAC, how to compile a successful Risk Management Plan, what are the objectives and requirements of the PASS (Post Authorization Safety Study) and how to structure the text and the process that the safety communication must do with interesting practical tips on editing and translations in local languages.

9. Contracts for pharmacovigilance outsourcing

There are more and more companies that need to rely on external pharmacovigilance services. After an appropriate vendor selection, it is good to define, among other things, the KPIs, the staff, the tools used, the deadlines and the needs of both parties.
The outsourcing contracts must be as thorough as possible, since the absence of official guidelines and therefore pharmaceutical companies must protect themselves to avoid incurring regulatory reporting non-compliance.
These are the advice of Raquel Martinez, Manager / EMEA Pharmacovigilance Agreements of Baxter S.L, and Giovanni Furlan, Safety Risk Lead and Director of Pfizer.

10. Digital Media in pharmacovigilance

Davide Bottalico, Digital Healthcare & Innovation Director of Takeda Italia, with Valentina Mancini, Associate Director Pharmacovigilance, Deputy European Qualified Person of Shionogi, made a nice speech about the relationship between digital media and pharmacovigilance. According to the GVP it is mandatory to collect AE from any source, social media and messaging services included. They therefore exposed the difficulty of fulfilling this task by contrasting regulations and possible new technologies to help this process. An example is the creation of a special algorithm to collect reports of adverse events on social networks, which must, in any case, be monitored and managed by dedicated personal skills.

11. Privacy in pharmacovigilance

What is the impact of GDPR on pharmacovigilance? Filippo Cerruti, Country Counsel of Italy and Greece of Amgen spoke about it, explaining that if it is true that the consent to data processing is the basis of privacy law, it is not always possible to obtain it. However, if it is information about drug safety that therefore impact on public health, the lack of authorization is superseded in favour of common welfare.

12. Engagement of the patient for the adoption of risk minimization measures

Mario Bertazzoli, Director and Group Head of Drug Safety and Reference Physician to EU QPPV in Helsinn Healthcare SA, and Paola Kruger, Patient Expert, EUPATI Fellow EUPATI Italy, are the speakers of the last session. Both have pointed out that non-serious reporting must always be taken into account by the MAH. From the clinical point of view, these, in fact, contribute to the correct definition of the dosage, while from the patient’s point of view they help in the generation of a drug that will guarantee them a better quality of life.

As a sponsor, we thank the warm welcome of the organizers, for the impeccable conduct of the two days and not least for the excellent quality and topicality of the issues dealt.