09 January 2020

Algeria issues New GVP Guideline

Things are changing fast in Algeria: It has only been a few months since a Note was published to describe revised Safety Reporting requirements (see Post) and the Algerian Authorities have now published a full Pharmacovigilance Guide with new changes to expedited reporting requirements.

The new Guide was produced by the "Centre National de Pharmacovigilance et de Materiovigilance" (CNPM) and includes a description of the local Pharmacovigilance System in Algeria. It covers the role of the stakeholders and includes a description of the obligations applicable to the Pharma Industry.




Among other topics, the Guide describes the expectations regarding the appointment of a Local Contact Person for Pharmacovigilance and for the maintenance and provision of the Pharmacovigilance System Master File (PSMF). The topics covered also include Procedures, Audits and Inspections, RMPs and PBRERs/PSURs, as well as Signal Management.

Regarding the Safety Reporting requirements, the Note published in June 2019 (see Post) reduced drastically the number of ICSRs that required submission in Algeria by removing the obligation to include foreign ICSRs. The new Guide brings yet more changes when compared to the June 2019 Note and here is a summary of the resulting applicable ICSR reporting requirements:

- Post-Marketing ICSRs, including cases originating from Non-Interventional Studies, must be submitted to the CNPM as follows:

  • Domestic Serious ADRs: within 15 Calendar Days
  • Domestic Non-Serious ADRs: within 90 Calendar Days
  • All Foreign ADRs: through the PBRERs/PSURs


Clinical Trials ICSRs must be submitted to the CNPM and Ethics Committees as follows:


  • Domestic Fatal/Life-Threatening SARs: initial report within 7 Calendar Days
  • Other Domestic SARs: within 15 Calendar Days
  • All Foreign ICSRs: through Annual DSURs

In other words, compared to the Note published in June 2019, there is no longer a requirement to submit Domestic Fatal/Life-Threatening Post-Marketing ADRs in 7 Days.
On the other hand, the requirements for Clinical Trials ICSRs now includes all SARs, whether they are unexpected (i.e. SUSARs) or not.

The Guide produced by the CNPM is only available in French and is unfortunately not available on the website of the Agency. The copy shared here was obtained from a contact in Algeria and user of this blog, whom I would like to thank for notifying me of this new and important guidance.

   → Link to CNPM 2019 Pharmacovigilance Guide (in French)
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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.

03 July 2019

Algeria updates Pharmacovigilance reporting requirements

ATTENTION !! UPDATE 09-Jan-2020:
This post is no longer current as the CNPM has published a new Pharmacovigilance Guide with revised ICSR reporting requirements (see New Post). The content of this post includes the resulting revisions (in Red & Highlighted in Yellow).


The Algerian Authorities have published an important revision of the Note describing the Pharmacovigilance reporting requirements in the country.

Until now, the "Centre National de Pharmacovigilance et de Materiovigilance" (CNPM) required that all Serious ICSRs and Clinical Trial SUSARs be submitted, including foreign reports. This meant that thousands of ICSRs qualified for reporting to the CNPM in Algeria, even though it is doubtful that the CNPM had sufficient resources to process such large volumes of information.

The Note published by the CNPM and dated 03-Jun-2019 will come as a relief to international companies placing medicinal products on the market in Algeria: The expedited reporting of foreign ICSRs is no longer a requirement and those cases are now only expected to be presented through the applicable periodic reports.



As a summary in English, here are the newly applicable requirements in Algeria:

- Post-Marketing ADRs, including cases originating from Non-Interventional Studies, must be submitted to the CNPM as follows:

  • Domestic Fatal/Life-Threatening ADRs: as soon as possible, within 7 Calendar Days
  • Other Domestic Serious ADRs: within 15 Calendar Days
  • Domestic Non-Serious ADRs: within 90 Calendar Days
  • All Foreign ADRs: through the PBRERs/PSURs

The Note also now clearly states that the submission of PBRERs/PSURs can be aligned with the EURD List.


- Clinical Trials SUSARs must be submitted to the CNPM and Ethics Committees as follows:

  • Domestic Fatal/Life-Threatening SUSARs: initial report within 7 Calendar Days
  • Other Domestic SUSARs: within 15 Calendar Days
  • All Foreign SUSARs: through 6-monthly Line Listings and Annual DSURs

As described in a recent article in the "Drug Safety" journal, the Algerian CNPM has not adopted the GVP Guideline for Arab countries published in 2014. With a 7-Day reporting requirement for Fatal/Life-Threatening ADRs, these new Requirements still deviate from the Arab GVPs and the underlying ICH E2D Guideline. Nevertheless, this revision represents a significant move towards international harmonization and will make compliance easier to achieve for the Industry in Algeria.

The Note issued by the CNPM is only available in French and is unfortunately not available on the website of the Agency. We obtained a copy from the CNPM, which we make available here, together with the previous version as a reference.









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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.

18 February 2019

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 !

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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.






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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.




29 November 2018

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


       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.

28 September 2018

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.








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.