Communications with Regulatory authority

Regulatory Authority Questions/Requests

The key stakeholder in the pharmacovigilance system from the decision-making perspective is health authorities, also known as regulatory authority, regulatory agency, competent authority, or health authority. For the ease of understanding, we will use RA as a term.

RA is the decision-making body for that particular country regarding the product and patient safety pertaining to the particular product. We are already aware of key RA e.g. FDA, EMA, CDSCO, MHRA etc.

Any RA may have a routine channel of discussion with MAH for various activities, or they may request additional or ad hoc data for ongoing evaluations about products. We will discuss only about pharmacovigilance related requests or questions from the RA.

Routine requests for communication between MAH and RA:

·       Application for approval of products known as a marketing authorisation application

·       Renewal of product approval  

·       Product label updates

·       Aggregate reports (PSUR , DSUR,PADER)

·       Risk management plan

·       Safety communication

·       Pharmacovigilance System Master File (PSMF)

Additional requests

·       Any data clarification requests about the above submissions, e.g. line listings, study reports, etc

Ad hoc requests for communication between MAH and RA

·       Device-related or combination product-related questions

·       Technical complaints or product quality issues

·       Individual case safety reports related

·       Urgent safety communication for signals

·       Signal notifications

·       Direct healthcare professional letters

·       Risk minimisation measures related

·       Study related e.g. protocol, ICF, conduct of study, etc

·       Inspection-related- follow-up to conducted inspections

·       Product benefit risk assessment evaluation of off-label use, abuse, misuse, etc

 

Common reasons for additional requests include: Frequently observed issues include new or unanticipated safety risks, gaps in efficacy evidence, requests for additional studies, and deficiencies in product quality, analytical controls, or manufacturing processes.

Preparation of response:

A request for additional data requires only coordination between different functions and a clear process, including a template to respond.

A request for additional data or analysis may need more time and a clear process.

Every MAH has an internal SOP on managing RA-related requests with timelines and templates with clear roles and responsibilities of each function.

An RA response from MAH should be concise, clear and factual, and hence it needs to be verified by reviewers and approvers.

A RA response with an action plan regarding a signal or a risk minimisation measure should clearly define the implementation and timelines. An RA response on label changes should clearly define the data to support this. An RA response regarding the assessment on a off label use, misuse or abuse or any such topics should clearly define the MAH position.

An RA response usually consists of the – Formal request from RA, details, background, evidence or analysis by MAH, conclusion, references and an appendix consisting of relevant documents e.g. label, data listings, implementation for risk minimization measures, DHPC draft, etc.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

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References:

1.     Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file

2.    
https://link.springer.com/article/10.1007/s43441-022-00430-z

3.     https://www.fda.gov/files/about%20fda/published/Good-Review-Practice---Refuse-to-File.pdf

4.     https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/best-practice-guide-measures-improving-predictability-submissions/responses-adherence-communicated-submission/responses-deadlines_en.pdf

5.     https://www.fda.gov/files/drugs/published/Best-Practices-for-Communication-Between-IND-Sponsors-and-FDA-During-Drug-Development.pdf

 

 

 

Audits and Inspections in pharmacovigilance

Audits and Inspections in Pharmacovigilance

 The words' audits' or 'inspections' can catch anyone off guard. Still, at the same time, they are a huge learning opportunity for us to identify deficiencies/gaps in our processes and how we handle our routine operations.

 

 What are some basic readiness actions we can take from the operations team (meaning the team that is actually handling pharmacovigilance tasks) and excluding the Quality Assurance (QA)/PV responsible team, who is actually the owner/leader on audits/inspections. 

There is depth of information on types of audits, inspections, how to prepare for them, corrective action, inspection report etc, but I will focus only on actual, easy and simple topics that are expected from any PV operations team member. Obviously, inspections responsible team and higher leadership roles in PV will have to know more than described herein. 

Inspection/Audit (A/I) readiness:

Personnel: An audit or inspection will have a Lead auditor/lead inspector at the Auditor/inspector end. If 2 or more regulatory authorities (RA) will conduct an inspection, then one RA will lead. The inspector/auditor will send a notification in advance about the inspection with an agenda. However, some inspections may be a surprise without notification or an agenda.

Internally at the MAH end, a list of functions/departments will be decided for roles and responsibilities based on the type of inspection and agenda. A dedicated SME are identified for each process, and this is part of inspection or audit readiness, which is described and documented throughout the year and is ready, not started after the inspection notification.

Location: The mode of A/I can be on-site, meaning in person, virtual or sometimes hybrid. For a local site specific A/I the availability of SME might be constraints and this should be clearly communicated and documented to auditors/ Inspectors (As/Is).

Agenda: A clear agenda—when provided in an As-Is state—significantly helps in identifying and distributing roles and responsibilities across various functions such as Regulatory, Clinical, QA, and Pharmacovigilance. In the absence of a defined agenda, there should always be an established framework at the MAH level, such as SOPs or a responsibility matrix, to ensure that the appropriate function addresses specific questions and requests efficiently.

Tools: Teams, SharePoint, Google Meet, Zoom and any other tools for communication within MAH team members and externally with As/Is need to be established. Avoid non-validated or generic channels like WhatsApp. Limit the document sharing or discussion on non-validated channels as this may infringe on data privacy and confidentiality. Printers should be dedicated for any prints or xerox avoiding any chaos or data sharing issues. Particular meeting rooms should be booked – a front room with As/Is and backroom for the MAH members.

 

1) Document readiness:

All documents pertaining to the processing of adverse drug reaction reports, like receipt of the reports by fax, mail, hard copies or soft copies received via website, call centre, sites, consumers/patients etc should be appropriately archived as per internal SOP (in line with HA requirements) and be available to be reproduced if requested by an auditor or inspector.

If there is involvement of other vendors, such as CRO (contract research organization)  or any other company to whom part of or all of PV is outsourced, then both MAH (marketing authorisation holder/pharma company)  a SDEA and additional documents as needed on data archival, should be clearly mentioned. Adverse drug reaction reports (SAE forms/ email form patient) etc are the most critical documents as they contain personal information of the patient protected under various country-specific laws and regulations, hence there storage and archival should be very clearly defined and followed.

 

All the other documents e.g. not limited to investigator's brochure, CCDS, protocol, SmPC, labelling documents, DSUR, PBRER, clinical study reports etc should also be defined regarding their availability (common share file location -access restricted) and who is responsible for ensuring the most recent versions are available to the team for reference, and the update process should be defined. 

 

The SOP should clear enough to address who, what , how and when at the company level so the processes are robust. More details on this can be found on GVP Module I.  All the team members processing the adverse events and handling PV should have training compliance and a training matrix to showcase the SOPs are followed.

2) Process consistency:

Process should be standardised to ensure all team members have a clear defined role and responsibilities to handle data. e.g. The adverse drug reports received from reporter, consumers, investigators etc may not be completely consistent or documented; there has to be an audit/inspection readiness document to prove that there are documents to help in identifying and making these reports more coherent for PV practices. Hence, how to do follow-up for missing information for adverse events, and what type of questions are critical, should be part of the process.

3) PV professionals: 

There has to be clear documentation on handling of PV functions per requirements by local and National HA eligibility rules. The CV, JD (Job description), training records, and training matrix should be clearly documented and regularly updated per requirement. Whenever required, only reading and understood document may not be enough, but a quiz or exam to ensure understanding should be implemented.

Many health authorities need medically qualified persons to handle PV functions of casualty assessment and medical narrative of adverse drug reaction reports. This has to be documented and the training and required qualification to be updated.

4) PV practices:

There has to be clear documentation on each and every process. For e.g. mail communication with reporters, investigators, patients, and consumers to reproduce CRO/MAH attempts to have complete medical documentation of all adverse drug reactions (ADR) reports. All calls, e-mails etc between any PV professional at CRO or  MAH also documented to make sure each ADR/PV follow up attempts are tracked correctly.

 The PV practices should also have assessment check points, if the process is effective and is being followed or not. Regular assessment of each SOP and process described in it should be planned and carried out. 

5) PV function readiness:

 Any request or actions from health or regulatory authorities in the form of requests, questions, queries, or audit findings should be actioned and discussed across the entire PV team. Any action or root cause that is found to be due to another department should be communicated as such to them. The pharmacovigilance department should always be audit/Inspection ready, as it is a department that concerns the safety of patient and any finding or gap will impact all other departments and patients' safety.

6) PV Database:

Knowledge on technical details on database used by MAH/CRO should be across PV team, and any data privacy measures, threats etc discussed and documented properly to ensure there are measures to avoid patient data leak etc. An appropriate team such as IT, Database vendors have to be involved to address this.

Post Audit/Inspection: A preliminary report should be generated and shared daily when an audit/inspection (A/I) extends beyond one day. This enables relevant stakeholders to review observations and prepare effectively for subsequent days. Following completion of the A/I, a draft final report summarising the findings should be circulated to all relevant functions. Responsibilities should then be assigned to the appropriate functions to address the observations and initiate CAPA (Corrective and Preventive Actions). Once the final A/I report is received and confirmed by the auditors/inspectors (As-Is), it should be formally distributed to all stakeholders. Based on critical impact, any actions to be taken should be immediately decided, and this definition of critical and the mode of action with timelines should already be described in the internal MAH sop.

 Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me: ThinkSharp Foundation http://thinksharpfoundation.org/#home

 References: 

 

1.                https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-their-quality-systems_en.pdf

2.                https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

3.                https://www.pharmacovigilanceanalytics.com/opinion/pharmacovigilance-audits-inspections-and-pv-analytics/

4.                http://www.hpra.ie/homepage/medicines/regulatory-information/pharmacovigilance-and-post-authorisation-safety/pharmacovigilance-inspections

5.                https://www.gmp-compliance.org/gmp-news/pharmacovigilance-inspection-metrics

 

 

 

 

 

 

Pharmacovigilance System Master File (PSMF)

 Pharmacovigilance System Master File (PSMF)

PSMF is the most critical and important document in PV! But what is it?

It is literally a file; only, as the days of big binders are over, it exists in digital format.

The Pharmacovigilance System Master File (PSMF) is a detailed record of how a company (MAH) monitors the safety of its approved medicines. It is not included in the marketing authorization documents and is kept separately. It must always be ready for inspection and should be shared with authorities within 7 days if they request it.

1. Legal requirement: 

As a part of the GVP module II it is mandatory for EU/EEA regions.

The PSMF should be in the EU, where the maximum of MAHs' PV activities take place, and the other option is where the QPPV (Qualified person for pharmacovigilance) resides. 

Every company needs to register PSMF in the Article 57 database of the EU. Each PSMF, when submitted electronically, will generate a unique code for the PSMF when the Eudravigilance system generates a message Eudravigilance medicinal product report message system (XEVPRM). Once a marketing authorization is granted, the EVMPD code will be linked to the PSMF in the system.

A. Compliance: For new Licenses and the renewal of products and inspections

B. Transparency and consistency to showcase a working PV system

C. Documentation: QPPV details in EU/EEA. For local PSMF in other countries (different terms may be used for QPPV e.g, India, its Person responsible for PV) similar template is followed.

D. PV system- AE, RMP, SIGNAL, and end-to-end PV-related SOP and working documents on how an AE is managed and how MAH ensures patients' safety.

A similar document is required in all countries globally, which is then called the local PSMF. Usually, any global company will create an EU PSMF and then, based on it, make a Local PSMF as needed.  

2. Content of PSMF

1. QPPV

2. Organizational structure of MAH 

3. Sources of safety data

4. Computerized systems and databases

5. Pharmacovigilance processes

6. Pharmacovigilance system performance 

7. Quality system

8. Annexures

3. Update of PSMF

Every MAH should have a process (SOP) for managing the PSMF, including draft, update and submission. In a big pharma, an independent QPPV office will manage this or for small to mid-sized companies, it will be handled by a vendor or by the same PV team. However, it is expected to have a process to set up PSMF and maintain it.

Any changes to QPPV, SOP, Vendor, agreements, or product portfolio will require an update to PSMF, logically. However, the update to PSMF frequency is dependent on each MAH. The EU regulation also defines major and minor changes. Major changes are QPPV details change, Safety database change, Org level changes (mergers, divestment), and training management system changes. Major changes to PSMF need to be implemented and communicated at the earliest to EMA. Local PSMF changes are then also implemented and communicated at the Local HA level.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me: ThinkSharp Foundation http://thinksharpfoundation.org/#home

References:

Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2) 2017 Guideline on good pharmacovigilance practices (GVP) - Module II – Pharmacovigilance system master file (Rev 2)

Risk assessment for quality issue

Any medicinal product, be it a device, drug, or combination, may have a quality issue that is also interconnected to pharmacovigilance. The quality issue itself may or may not lead to an adverse event (AE), and the ones associated with AE will be tracked in the global safety database, at the ICSR level. However, certain quality issues may require aggregate analysis and market actions that can impact patient safety and have a public health impact. These quality issues will require medical assessment on how serious the risk is, which is performed by a medical safety physician from pharmacovigilance.

These are typically non-product-specific and are deviations in manufacturing, packaging, or distribution of the product. These deviations or non-compliance with health authority specifications or internal marketing authorization (MAH) specifications are analyzed, evaluated, and then a recommendation is made by the pharmacovigilance team on the outcome of this deviation and its impact on patient and public health.

The following are the criteria /source of information used to perform the risk assessment of the deviation/quality issue/non-compliance. Although these are different terminologies and can mean different things as per the MAH internal process, for the sake of this blog, we will use them interchangeably. 

1. Global Safety database:

Using a search strategy that can retrieve all cases about that particular quality issue, all ICSRs should be analyzed and evaluated.  The time period is from the date of manufacturing of the product/ but ideally, from the date of market launch of the product until the quality issue was identified. If the dates are not available or complicated to retrieve, 3 years can be an ideal period retrospectively from the date of identification of the quality issue.

Most important is to choose the correct search strategy to retrieve the correct cases, the search strategy should be broad enough, but to avoid noise, narrow to exclude non-relevant cases. If the quality issue is contamination, retrieve cases of all reported contamination, color change issues reported.

2. Other sources:

Any literature articles published and available publicly about the reported quality issue. The search period is the same as explained above.

Any previous similar quality issues that occurred with similar risk assessment reports should be analyzed. 

Request toxicology reports, stability testing results, and investigation analysis done on the affected batches vs the non-issue batches. 

3. Risk assessment:

Once all the data is available, as a safety physician, an assessment needs to happen regarding the impact of the error on public health. While assessing, consider the type of adverse events that can occur or have occurred. The seriousness, severity, treatability, reversibility, and preventability of these adverse events. The patient population affected, e.g. comorbidities, age (geriatric or pediatric). 

4. Conclusion 

A conclusion should be provided regarding the mitigation of this risk, market recall being the most conservative for serious public health impact, sending a direct healthcare professional communication, change in the label, education material update etc.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

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 References:

ICH guideline Q9 (R1) on quality risk management 

FDA – Recalls, Corrections, and Removals (21 CFR Part 7) 

Session 1- Complaints Investigation & Review- Jaidev Rajpal + Avinash Joshi 

Post-Authorization Safety Studies (NI-PASS)

There are two different studies that a Health authority may request an MAH (Marketing Authorisation Holder) to conduct after authorisation. One with the key objective of safety and another for efficacy, although it's always that we will get both outputs, and safety and efficacy go hand in hand.

So the post-authorisation efficacy study and post-authorisation safety studies (PASS). Both these studies can be interventional or non-interventional, and each MAH has its own processes to define and implement these regulations.

PASS falls under the realm of pharmacovigilance; therefore, we will discuss it further in this blog. 

PASS includes the following when non-interventional. Non-interventional studies wherein the product is prescribed and administered to patients as a part of routine clinical practice. 

PASS when interventional, they are our clinical trials. 

•  HCP surveys conducted for the effectiveness of any risk minimization measures implemented by MAH ( e.g., providing patient alert cards to each patient and explaining to them the risk it outlines
• Public registries that MAH has to enroll patients of approved therapeutic indications and characterise the known risk, or establish the safety profile
• Consortia (one or more MAH form the group to conduct a particular registry to gather data)
• Market surveys to characterise and analyse the product safety.

Post-authorization safety studies (PASSs) can be mandatory or voluntary.

• Mandatory PASSs are required by Health Authorities. For example, they may be needed when a medicine has been approved under exceptional circumstances or when the Pharmacovigilance Risk Assessment Committee (PRAC) asks the MAH to conduct PASS to confirm the safety profile, characterize the risk or measure the effectiveness of risk minimization measures.

• Voluntary PASSs are started by MAH themselves. These can include studies that the company chooses to do, or studies that are part of a risk management plan but not formally required by any Health authority.

Starting January 2025, all marketing authorization holders will need to use the IRIS platform to manage their post-authorization safety studies (PASSs) after the initial submission in the EU, as per EMA. PASS studies are also registered in the EU PAS register/now called as catalogue of real-world data studies, which is a European Union register electronically for post-authorization studies on the European network of centers for pharmacoepidemiology and pharmacovigilance (https://catalogues.ema.europa.eu/). A EU CT number is mandatory for all PASS registered by MAH. 

Table on the category of PASS:

Category	PASS	PAES
Category 1	Imposed (GVP Module V)	Imposed
Category 2	Imposed (Commitment in MA, exceptional approval)	Imposed
Category 3	Voluntary, Part of RMP commitment	Required/voluntary
Other		Voluntary

Every PASS study submitted as imposed PASS to EMA will require a Study protocol, major amendments to the protocol after the PRAC comments are received/ for nationally required PASS- assessment will be done by that national health authority. MAH will then need to submit interim study reports, final study reports to EMA, and also provide the summary and details of PASS in PV documents like PSUR, RMP in the respective sections. Any change in the safety profile of the product due to ongoing PASS based on interim results will then be submitted as part of an update to RMP, smpc, or based on the frequency and timing of PV documents. The timelines and requirements of PASS progress to EMA are specified in the study protocol approval and will be part of study planning.

EMA publishes the outcome of PASS in the EPAR (European public assessment report ) and on EU PAS register platform.

Key takeaway:

As PV  professional, you will be involved in PASS depending on your role in the organisation, but having a basic understanding helps. To know the definition of PASS, how they become part of RMPs, and PSURs. Knowing the concepts helps to review or take strategic decisions from PV for protocols and outcomes of studies and their impact on the safety of the product.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me: ThinkSharp Foundation http://thinksharpfoundation.org/#home 

References:

1. Non-interventional imposed PASS are set in Articles 107n-q of Directive 2001/83/EC.

2.https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass#non-interventional-imposed-pass-questions-and-answers-6931

3. https://www.ema.europa.eu/en/documents/other/guidance-format-and-content-protocol-non-interventional-post-authorisation-safety-studies_en.pdf

4. guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pdf

5. GVP V module and EMA website

Risk minimization measures and implementation

 Implementation of risk minimization measures 

In my earlier blog on Risk minimization measures (Apr 2026), we covered what risk is in PV and what routine and additional risk minimisation measures are. Today, we will see the implementation of these risk measures. Implementation drives the success of anything rather than only the idea itself.

Risk minimization measure:

To understand the implementation it's critical to understand the difference between messages and tools about RMM.

RMM messages	RMM tools
the key information (i.e. not the full wording) about the risk and the actions intended to be taken by the healthcare professional or the patient for minimising the risk	The tool by which the RMM messages are disseminated and adherence to the intended actions for risk minimisation is supported and/or controlled, belonging either to the category of routine or additional RMM tools.
Scientific content, but as per the targeted audience and platform e.g. HCP vs patients, Patients vs caregivers, and digital vs physical copies	Educational/Safety advice tools that include a patient alert card, an HCP checklist for the risk, HCP educational leaflet
No promotional language	Risk minimisation control tools that include HCP qualification, Hospital accreditation, traceability systems, patient certificates, and a systematic process for patient documentation in the product prescribing programs
The key messages should not be duplicative of Smpc or PIL . The main outcome we should achieve is that the educational advice to patients should be about the particular risk and its management.	To select the correct tool, the following criteria need to be considered: seriousness, severity of risk, patient target population, Healthcare professional target population for the RMM, product classification and details (dosing, administration, etc.), possible burden of the RMM on the healthcare system, and effectiveness of the RMM.

Once the RMM message is finalized, for the implementation the tool should be selected accordingly.

A. Develop the plan for implementation: Some questions/points that need to be answered are

•  Is the RMM implementated gloablly or locally?
• Who is the target audience?
• Ensure that while choosing the healthcare system and settings and the typical patient environments are considered.
•  RMM message should be considered for adequacy, comprehensibility of language, and usability as well as user-friendliness of the RMM material

B. Distribution plan:

• Who /Which functions will be leading the distribution globally and locally?
• Number or recipients as per the classification ( e.g. how many HCPs are subdivided into printed vs web form)
• Electronic and physical systems for the distribution (Webpage for HCP alert card distribution, patient enrollment database to monitor and archive tests)
• Map all the steps with start date and end date (if available)

It is critical to ensure the outcome expected from RMM and RMM tools is well thought out for patient safety and they should be supportive for achieving it rather than causing a burden of PV and healthcare systems. RMM tools and RMM messages are key to reducing the burden of risk by helping with prevention and early diagnosis and treatment.

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me: ThinkSharp Foundation http://thinksharpfoundation.org/#home

References:

GVP Module Risk Minimisation Measures

Artificial Intelligence in Pharmacovigilance (AI in PV)

We all keep hearing about Artificial Intelligence everywhere, and it's no surprise that it has also consumed the Pharmacovigilance industry. While I am no AI expert, I tried to talk about a few things that, as a safety physician found fascinating, we have achieved with the use of AI, and a few things that I am eagerly awaiting to be implemented in PV.

The technological revolution that helped us achieve tremendous transformation, some examples below, not just in PV but in the healthcare industry, as noted below. 

1. Identification of disease has really become faster, cost-efficient, and more cost-effective. 

2. Predicting the disease progression and at-risk population has also become easier with the help of technology, which allows patients to know the early signs, symptoms, and Healthcare providers to have tech-assisted platforms to then also utilize faster diagnosis.

3. We are using diagnostic algorithms, telemedicine, virtual patient monitoring, and robotic surgeries. 

4. AI-powered tools assist in drug discovery, automation in manufacturing and distribution, virtual and decentralized trials, and large data volumes are managed by machine learning.

5. Data collection has become easier due to wearable devices.

In the pharmacovigilance world, we have also made some good strides with respect to embracing automation, and I have noted some well-known examples below.

1. ICSR: Automation has been implemented for duplicate check during case intake and triage, making it less time-consuming and cost-efficient not to manually check during intake if it's an initial case or follow-up.

2. Literature monitoring: An AI-powered literature database that allows for excluding and including articles based on the four minimum criteria and the parameters added at the product level (brand name, ingredient, MAH territory).

3. Signal detection: Many signal tools are available that allow to use of statistical models for signals and unified signal outcomes from various sources. 

4. RMP and Aggregate report management: 

Various tools and databases are available to track, schedule, and submit aggregate reports.

RMP tracking and RMP commitments are also tracked via tools that allow for ensuring compliance. 

There are multiple advantages of technology integration, and those we are already aware of; however, to ensure the summary below includes some most critical advantages. 

1. Cost efficiency - Intelligent and smart cost utilization. 

2. Speed and real-time analysis - continuous monitoring of data from diverse sources enables quick and timely identification of new signals and hence provides risk management.

3. Improvised and consistent quality: Automation and AI integration have led us to move from volume-based to value-based.

4. Increased efficiency - Automate labor-intensive tasks, allowing faster processing and analysis of large volumes of data. 

5. Scalability- Automation across global databases and platforms has led to facilitating signal detection for large databases. It has also allowed to use of AI/Automation to generate scientific outputs.

However, there are a lot of opportunities still existing in pharmacovigilance for not only embracing technology but integrating it for pioneering patient safety, and I have noted a few that I could pick from various sources.

1. Structured and regulated processes 

2. Time-driven assessments to be performed regarding the implementation of technology.

3. Patients' outcomes are monitored closely after the implementation of technology. 

4. Data privacy and confidentiality are unified to have simpler and effective implementation

5. Use of robust database, human scientific intelligence for validation, security, transparency, and validity. Dataset standardization with collaboration and communication.

6. Implementation of technology has to be in parallel to training human resources on technology, collaboration

7. Implement technologies that use cloud-based solutions, open-source platforms to improve reach, knowledge sharing, and collaboration.

Some of the examples about integrating technology are AI-driven case processing, allowing only relevant cases to come into the medical workflow, and Natural language processing (NLP) for literature mining, AI-driven signal detection for classification of signal, and addressing the impact of signal.

Many avenues exist for integration of AI in technology, and if we are open-minded to accept them, we will be able to achieve the patient safety outcome we all work for i.e. safe and effective drugs in the market.

Written by:

Written by:

Dr.Shraddha Bhange.

Connect with me Via comments below. (I do not respond to Facebook messages)

Support the cause of better rural education with me: ThinkSharp Foundation http://thinksharpfoundation.org/#home 

 References:

VigiAccess: Promoting public access to VigiBase - PubMed

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-addendum-i-duplicate-management-suspected-adverse-reaction-reports_en.pdf

(PDF) Artificial Intelligence in Pharmacovigilance: a regulatory perspective on explainability

Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER | FDA