Experts Corner: Risk Management Plans (RMPs) and Their Role in PV

Leading the Way in Pharmacovigilance

Zenith PV Solutions Inc., a premier pharmacovigilance consulting service provider in Canada, recently hosted a live expert panel session. This event, part of Zenith’s commitment to bringing the latest updates and fostering in-depth discussions in the field, highlighted the pivotal role of Risk Management Plans (RMPs) in pharmacovigilance (PV).

Our guest panelists and masters in their fields, Robert Milne – Manager, Patient Safety, Global Patient Safety Pharmacovigilance, EMD Serono, A business of Merck KGaA, Darmstadt, Germany and Elisabete RegoPatient Safety Manager, Global Patient Safety Global Markets, AstraZeneca Canada Inc, share their valuable insights on various aspects of RMPs and their role in PV in the Canadian market, the synopsis of which is presented below.

Expertise in Action: The Role of RMPs

An RMP is crucial in identifying, mitigating, and monitoring drug-related risks. Constantly evolving, these plans are essential for ensuring patient safety throughout a drug’s lifecycle. Reflecting international guidelines and tailored to the Canadian market, RMPs symbolize the adaptability and foresight central to Zenith PV’s approach.

What are the standards to consider while planning the RMPs?

While planning an RMP, goals should always be transparent, data proper and patient safety should be the top priority. There are some grey areas that can be explored while planning an RMP which primarily include: availability of Canadian addendums, Canadian epidemiology studies, previous RMPs, information on number of patients and potential impact of drugs in year 1 and year 5.

Emphasis also lay on additional PV routine activities, educational materials, prospective relation of education materials to Canadian population and the need to localize the RMPs as per Canadian population. In addition, safety concerns and other information can be readily captured from European RMPs in cases where limited data is available for certain products or when there is a specific Health Canada request, all while keeping patient safety as our primary inclination.

Of note: Preparing the RMPs and adjusting them as per the Canadian specific regulations might delay the process of launching the products, but the key should always be effective and dynamic communication with Health Canada to tackle this.

What are the expectations of Health Canada from an RMP and how can we ease out the fulfilment of the same?

As per the patterns observed from recent Health Canada audits and enquiries, it seems like Health Canada is asking for more astringent information and in order to facilitate the same, there arises a need to have more post market studies, additional and detailed data on different populations such as geriatric, pediatric, and likewise for different races, as well as pregnancy registries.

The requirements also depend on the product in question and might differ for different products. As an example, since the data on the risk of biologic products is limited, the need for more post-market studies in this group is apparent.

How can we make RMPs a success story in Canadian PV system?

RMPs are a new and emerging component in Canadian PV system, hence, they come along with a challenge. In order to make RMP submissions a success, diverse internal teams including Regulatory, Medical and Marketing should all be thoroughly educated and aligned together, companies should be up-to date with latest guidelines and there should be a unidirectional portfolio, always. As the prime and ultimate goal is always patient safety, the departments that have direct interaction with Health care professionals need to be well-educated to be able to detect the safety signals properly. Education of external vendors is also of significant importance for identifying the new signals.

What about updating the RMPs?

Speakers suggested that updating the RMPs depends on the effectiveness of RMPs along with other factors like the product(s) in question, outcome(s), signals received, and the type and number of cases captured.

If conditions are favourable and the RMP is effective enough, leads can be lowered down or removed from some activities. Also, RMPs can be modified over the years to make them less astringent and safety concerns can be removed based on ASRs, PBRERs and signal management reports.

However, in other case where an RMP is not effective, and signals keep coming-in, risk mitigation measures need to be changed.

RMPs for Opioids?

Health Canada has audited some opioid MAHs recently and reinforced certain aspects of their routine activities, including detailed literature search and investigating the use of the product within the years and compare it to the original RMP data that has been submitted. It is important to look at the prescribing trends and how they have changed over the years when it comes to RMPs for opioids.

Going forward, there is a good probability that Health Canada can combine the requirements for opioids and other products and make it as a one guidance document as far as authoring and submissions are concerned.

What is the role of RMPs in GVP audits?

There is a good opportunity to improve when it comes to RMPs in GVP audit. What we know so far is that Health Canada auditors will not ask for RMPs during their pre-inspection and inspection stages, but it will change very soon, and we need to be ready for it. Also, when it comes to HC inspections, the best practices of RMP training are training the vendors as well as internal staff and ensuring that the trainings are appropriate and effective. Training should always be based on the product monographs and product education and a holistic approach should always be adopted to include vendors in the training.

Conclusively, it can be said with utmost prominence that the RMPs are now an integral part of the Canadian PV system and should always be progressive, differentiated reports and should emphasize on proper landscape of the product. Irrespective of the type of products and the spectrum it covers, RMPs should always focus on patient safety. A thorough understanding of the objective of these reports and subsequently, appropriate training of staff and vendors is the primary key to successfully authoring, submitting an RMP from a Health Canada inspection or audit point of view.

Zenith PV Solutions Inc.: Your Partner in Pharmacovigilance

At Zenith PV Solutions Inc., we’re not just observers but active participants in shaping the future of pharmacovigilance. Our expert-led sessions are a testament to our dedication to providing cutting-edge insights and practical solutions. We offer unparalleled support in developing and updating RMPs, ensuring compliance with Health Canada’s stringent standards.

Engage with the Experts

For bespoke RMP guidance or any pharmacovigilance service needs, connect with Zenith PV Solutions Inc. We’re here to elevate your pharmacovigilance strategy with our expert consultancy and tailored solutions.

Contact Us

Reach out to a senior Zenith PV partner today at or call 416 807 5441.


  • Guidance Document – Submission of Risk Management Plans and Follow-up Commitments
  • PV Panel Discussion on RMPs, organized by Zenith PV (05 Oct 2023)



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