Interpersonal skills during audits and inspections…

Until now, I have used this blog to report on changes in the requirements applicable to Pharmacovigilance. This time is different and I would like to share the learning I took from a project I am involved with.

The story starts in the summer of 2017 when I received a call from a contact in the Global Pharmacovigilance group at Bayer. This contact knew me as a Pharmacovigilance Auditor and asked whether I would be interested to work on a coaching module. This module was part of a training programme the company was putting together to make people better prepared for Pharmacovigilance Audits and Inspections.

The Coaching Concept

One of the requirements was that I partner with another consultant that Bayer had identified for the project: A stage actress also working as a personal coach… How interesting !!

This is how I met Karin Seven, who has been working with professionals in the pharmaceutical industry for more than 20 years, helping them increase the impact of the messages they want to deliver during the course of their professional life.

Based on the requirements and objectives set by Bayer, we developed a concept for a full-day of individualised training following a standard agenda:

• During a baseline Mock Interview, I would cover topics relevant to each student in the same manner as I would do during a real audit, while Karin observed.
• Following an assessment review, we would then collectively discuss the strengths and weaknesses of the student, from both the content and behavioral perspective.
• Based on the assessment, Karin would work with the student through various exercises tailored to the individual’s needs, while I would review the documents requested during the Mock Interview. The exercises proposed by Karin are intended to help correct a range of personal habits that can include posture, breathing and voice coaching.
• I would then lead a second Mock Interview, providing the student the opportunity to put the lessons learnt into practice.

Examples of behavior to avoid…

Before I provide my feedback on this experience, I thought I would share a few examples of behaviors we sometimes see during audits and inspections, and which I DO NOT recommend:

• Appear disinterested and avoid eye contact
• Overuse filler words, e.g. “Humm” every two words
• Make an effort to refute any opportunity to cooperate in the audit/inspection process
• Talk with an inaudible voice that can be covered by the noise of the air-conditioning system
• Respond to questions with answers as long as possible, with a monotone voice and as fast as possible so there is little chance for anyone to take accurate notes
• Start answering before the auditor/inspector finished his/her question
• Start the interview with a lengthy PowerPoint presentation to waste time
• Act in such a way that the auditor/inspector feels like a pupil being taught a lesson…

The benefits of our Coaching Module

I am most impressed with the changes I can sometimes measure between the initial and the second Mock Interview. It is true that a few of our students did not really need much help, as they were already visibly confident in their responses but for others, I was amazed to see how much progress they made as a result of the coaching session. Instead of looking shy or confused, they managed to make slight behavioral changes that made their message much more impactful. They became more interesting to listen to, more self-confident and more convincing.

From an auditor’s perspective, it is of course clear that it will not be sufficient to deliver your message in a pleasant way if the content does not meet the expectations. We are trained to rely on evidence to assess compliance and you will not be able to hide the reality of a poor Pharmacovigilance System just by providing responses in a confident and decisive manner. However, clear and articulate responses delivered with confidence and ownership can only make the interview process more efficient and interesting for all those involved.

My part was rather easy: I just helped students become more familiar with the type of questions they may face during actual Pharmacovigilance Audits and Inspections. In my view, the coaching provided by Karin helped many of the students deliver their message in a more convincing manner. Even though this may not improve dramatically the outcome of an audit or inspection, I am convinced that the changes I have witnessed with some people will have a great impact for them, not only in their professional but also in their personal life if they choose so.

What’s your take on this ?

Please feel free to use the comment field at the bottom of this post to share your experience or comments. I am particularly curious to hear from my colleagues, Auditors and Inspectors…

Many thanks in advance !

_______________________________

Thierry Hamard (LinkedIn Profile) is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

_______________________________

Karin Seven is working as a Coach and Trainer for more then 22 years. She is a qualified actress, working on stage for more than 30 years as actress or director.

Her expertise covers performance skill including speech, body language, posture, mindsets and radiance.

She is also the author of the book PowerAct - Deliver your best Performance, which is published in German by Haufe.

Revised ABPI Guidance for PV in Market Research

As reported in Safety Observer N°150 of November 2018, the ABPI (Association of the British Pharmaceutical Industry) has worked with BHBIA (British Healthcare Business Intelligence Association) to produce a revised version of their guidance on collecting Adverse Events, Product Complaints and Special Situations Reports during Market Research Programmes (MRPs). This is Version 4 of this valuable guidance document, which was first issued in October 2009.

In addition to changes related to Personal Data Protection, the main change concerns the collection of contact details when information is collected directly from patients/consumers in order to enable the appropriate follow-up of Adverse Events by the MAH.

For those who are not familiar with this document, it includes a series of useful annexes including example wording for the contract with the Market Research Agencies, templates for Data Collection and Reconciliation Forms, as well as interview scripts covering a range of scenarios.

The information presented on the BHBIA website also includes the Microsoft Word templates for the Data Collection and Reconciliation Forms, as well as suggested wording for Market Research Materials and a series of “Quick Guides”.

→       Link to ABPI News Release

→       Direct link to BHBIA/ABPI Guidance on PV in MRPs

→       Link to BHBIA Page

Thierry Hamard is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

Established products to exit EU list of Black Triangle Products ?

As reported in Safety Observer N°148 of September 2018, the EMA has published the minutes of the 100th Management Board meeting, which took place on 06 and 07-Jun-2018.

The Board discussed a great variety of topics, including Brexit and lessons learnt after the first EMA Public Hearing. It also included a discussion on a report exploring the experience made with the list of products subject to additional monitoring, also known as the list of Black Triangle Products.

As described in GVP Module X, all medicines on the list must be identified with an inverted Black Triangle, which is displayed in their package leaflet and in the SmPC. This system was derived from the Black Triangle scheme already in place in the UK to highlight the medicines under close scrutiny by the authorities, which was expanded throughout Europe with the implementation of the 2010 Pharmacovigilance Legislation. The EMA published the list for the first time in April 2013 and it is reviewed every month by the PRAC.

There are a few reasons that can make a medicine enter the list, knowing that it should remain on the list for 5 years unless the PRAC decides otherwise:

• It contains a new active substance or a new biological/biosimilar product

• It has been given a conditional approval, or approved under exceptional circumstances or with specific obligations on the recording of suspected ADRs

• The company that markets the medicine is required to conduct a post-authorisation safety study (PASS)

One of the main conclusions of the report discussed by the Board is that the latter criterion has led to the inclusion of a large number of established products in the list (see item B.9 in the minutes). This is reportedly of limited value and the PRAC supports that this category of products should be removed from the scope of additional monitoring.

Based on the current list (i.e. Revision 58 dated 25-Jul-2018), there are 57 out of 346 active substances that are on the list only because of a required PASS. They are not all established products but those are easy to spot because the number of products and MAHs concerned is so large that they need to be presented in Annexes separate to the list. For example, the list of Domperidone-containing medicinal products (Annex X) is 6 pages long. Even though each formulation / MAH / Country is presented, it still concerns a large number of products indeed.

Based on the report and the opinion of the PRAC Committee, this may change in the future and these products would no longer qualify for the Black Triangle scheme in the EU. Following endorsement by the Heads of Medicines Agencies (HMA), the report will be sent to the European Commission for further consideration and decision by the European Parliament and Council.

→       Link to EMA Management Board Meeting Page

→       Direct link to EMA Management Board 100th Meeting Minutes

→       Link to EMA Page: Medicines under additional monitoring

→       Link to EMA Page: List of medicines under additional monitoring

Thierry Hamard is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

EMA Guidance on ICSR data from EudraVigilance

Everybody should know by now but in case you missed it, the EMA published much-awaited guidance over the summer to clarify the obligations of MAHs to record information on ICSRs they can access in EudraVigilance.

Since the implementation of the New EudraVigilance on 22-Nov-2017, MAHs are given access to all ICSRs contained in the EudraVigilance database. The MAHs are now responsible to access EudraVigilance to retrieve all ICSRs related to their medicines and first received by National Authorities.

There was however no guidance regarding the obligations of MAHs in relation to ICSRs submitted to EudraVigilance by other MAHs or regarding those ICSRs available in EudraVigilance prior to 22-Nov-2017. This has caused a lot of pain and confusion, especially for MAHs of generic products who could not exclude ownership of the suspected products in many ICSRs they became aware of.

This gap has now been closed by the EMA and the Note for Clarification published on 23-Jul-2018 brings much needed guidance:

• Regarding the ICSRs available in EudraVigilance prior to 22-Nov-2017, the Note clarifies that MAHs have no obligation to screen EudraVigilance for cases that they do not already have in their own database. In the same way, the MAH have no obligation to record in their database those ICSRs they become aware through activities related to Signal Management in EudraVigilance.

• Regarding the ICSRs submitted by other MAHs to EudraVigilance, the Note clarifies that MAHs have no obligation to record these in their own database.

Although some will argue this took a long time and could have been better anticipated, this should come as a relief for the industry. It also sets a clear standard for Regulatory Inspections.

→ Link to EMA Page: Access to EudraVigilance data

→ Direct link to Note for Clarification

Thierry Hamard is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PVFocus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

Medication Errors in France: Q&As now published !

The publication of the new version of the French Good Pharmacovigilance Practices in February 2018 brought some confusion regarding the obligation for Marketing Authorization Holders (MAHs) and "Exploitants" to submit specific reports to regulatory bodies outside of the EudraVigilance network.

As mentioned earlier (link to our June2018 post here), we questioned the French Agency about the apparent additional requirement to submit Reports of Medication Errors with no Adverse Reaction, as well as Reports of Abuse or Dependence to medicines containing psychoactive substances.

The response we received brought valuable information and announced the imminent release of a Questions & Answers Document to address the need for clarification. The wait was short and the ANSM has now published this Q&A Document, which provides additional information on the role and obligations of the MAH and "Exploitant".

In line with the response shared earlier, it confirms that there is no obligation for Pharma Companies to submit Medication Errors without adverse reactions to the dedicated ANSM Medication Error Desk. As already mentioned, all confirmed Medication Errors (with or without Adverse Reactions) must be assessed in the corresponding PSUR and taken into account in the evaluation of benefits and risks of Medicinal Products.

In the same way, the Q&A Document clarifies that there is no obligation for MAHs and "Exploitants" to submit reports of abuse or dependence to medicines containing psychoactive substances to the Dependence Evaluation and Information Center (CEIP).

These clarifications will be reflected in the French Good Pharmacovigilance Practices, which should be revised accordingly in the near future.

Please note that the Q&A Document also clarifies the expectations regarding additional aspects of the local Pharmacovigilance System including the responsibilities of the local contact person for Pharmacovigilance, local PSMF, local Signal Detection activities and Risk Management, etc.

➝ Link to ANSM Q&A on the French GVPs (in French)

___________________________

Raphaëlle KUHN is a Pharmacist with over 9 years of experience in the pharmacovigilance and clinical trial safety area. She has been working as a Pharmacovigilance Consultant within SUNNIKAN Consulting for 6 years where she supports clients in quality management activities and has conducted over 80 audits internationally.

Raphaëlle also contributes to the monthly Pharmacovigilance Regulatory Intelligence bulletin Safety Observer with regards to the French announcements.