Speaker Opportunity at Pharmacovigilance Conference organised by Chandigarh College of Pharmacy

 It was an absolute pleasure to attend conference on pharmacovigilance and patient safety at Chandigarh College of pharmacy on occasion of National conference of pharmacovigilance and Clinical research. I owe this opportunity to Dr. Sridhar Yeshamaina, a well-known PV and clinical research expert and a one of the key person in my professional circle who motivates me to learn PV more every day.

 

I had privilege of talking about  Seriousness & Expectedness & Causality Assessment Criteria . I talked about how pharmacovigilance and drug pharmacovigilance from ICSR management, RMPs, risk minimization measures, signal detection impacts patient safety. The impact of seriousness , expectedness and causality is for the purpose of regulatory reporting but it actually impacts patients a lot. A serious unexpected and related case impacts patients health outcomes, cost and quality of life. 

 

National conference of pharmacovigilance and Clinical research 2022 is a conference which was organized by Chandigarh College of Pharmacy (CCP), Landran, Mohali, Punjab, India under the aegis of Chandigarh Group of Colleges (CGC), Landran it has many accolades such as Awarded as Best Private Pharmacy College in India in 2016). Chandigarh College of Pharmacy (CCP) is an affiliate of Chandigarh Group of Colleges (CGC) which was established under Sri Guru Ram Das Educational Society (Regd.) under the dynamic leadership of  SatnamSingh Sandhu, Chairman and Rashpal Singh Dhaliwal, President. CCP under the aegis of CGC is a premier institute in the northern region of India, setting benchmarks in the field of pharmaceutical sciences with its research.The institution was established in 2005.

The chief guests of honour were Prof Dulal Panda,  Director NIPER, Prof.Dr.Rajeshkumar Goel APTI President, Punjab branch, Rashpal Singh Dhaliwal, President CGC, Landarn. 

The conference was organised beautifully and i had most warm hospitality thanks to Organizing secretary

Dr. M.Arockia Babu, Director-Principal, Chandigarh college of pharmacy, landran.

 The esteemed speakers were Dr. Minaxi Khalera,Director-Clinical Research,AstraZeneca Pharma India Limited,Dr. Sridhar Yeshamaina,Senior General Manager - CDMA,Head - Global Pharmacovigilance,Clinical Development & Medical Affairs,Hetero, Hyderabad,Ms. Rajni Jha,Pharmaceutical Consultant,Pharmaceutical Regulatory Affairs and Quality,New Delhi,Dr. Vallabh Deshpande,HOD Pharmacovigilance Operations,Glenmark Pharmaceuticals Limited and many others.

This conference was attended by approx 200 members comprising students from all pharmacy courses and domain experts . It was a huge success as students from all nearby institutes were welcome too join. It gave them industry perspective as well in terms of job and entrepreneurship opportunities in this domain. It infused the importance of patient care through PV .

 

Topics of the conference were very interesting and were handpicked to make them relevant to Indian Pharmacovigilance scenario and the speakers chosen for the topics were absolute delight as they poured their expert knowledge about these topics.

More details about conference and topics an e-book available on website to download:https://www.ccpmohali.org/public/documents/abstract-book-2k22.pdf

Organizers details: https://www.ccpmohali.org/

Written by:

Dr.shraddha Bhange.

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Audits and Inspections in Pharmacovigilance

 Audits and Inspections in Pharmacovigilance

 Audits or Inspections word can catch anyone off guard, but at the same time its a huge learning opportunity for us to find deficiencies/gaps in process and how we handle our routine operations.

 
Being part of audit and inspections in the past, but also recognizing that I am not yet expert on this or far from expertise, I just figured learning by sharing would be a good revision to be audit/inspection ready.

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

There is depth of information on type 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, QA team and higher leadership roles in PV will have to know more than described herein. 

To give an example and put things in perspective, MHRA (Medicines & Healthcare products Regulatory Agency)  conducted 22 inspections in 1 year between April 2017 and March 2018, which took tremendous amount of time, money and resources of both, pharma companies and MHRA. During these inspections, MHRA identified 89 major findings in risk management plans, noncompliance in quality systems, analysis of safety data, and management of adverse drug reactions.

1) Document readiness :

All the document pertaining to processing of adverse drug reaction reports like receipt of the reports by fax, mail, hard copies or soft copies received via website, call center, 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 auditor or inspector.

 

If there is involvement of other vendor such as CRO (contract research organization)  or any other company to whom part of or all of PV is outsourced then both MAH (marketing authorization holder/pharma company)  a SDEA and additional document as needed on data archival should be clearly mentioned. Adverse drug reaction reports (SAE forms/ email form patient) etc are the most critical document as they contain personal information of patient protected udner 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 investigators brochure, CCDS, protocol, SmPC, labelling documents, DSUR,PBRER, clinical study reports etc should also be defined regarding there availability (common share file location -access restricted) and who is responsible for ensuring 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 company level so the process 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 training matrix to showcase the SOP are followed.

 

2) Process consistency:

Process should be standardized to ensure all team members have clear defined role and responsibilities to handle data. e.g. The adverse drug reports received from reporter, consumer, investigators etc may not be completely consistent or documented, there has to be audit/inspection readiness document to prove that there are document to help in identifying and making this reports more coherent for PV practices. Hence how to to do follow up for missing information for adverse events, and what type of questions are critical for should be part of 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, training matrix should be clearly documented and regularly updates per requirement. Whenever required, only read and understood document may not be enough, but 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 also 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, consumers to reproduce CRO/MAH attempt 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 form of requests, questions, query, audit finding should be actioned and discussed across all PV team . Any action or root cause that is found to be due to other department should be communicated as such to them. Pharmacovigilance department should always be audit/Inspection ready, as it is department that concerns 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. Appropraite team such as IT, Database vendors have to be involved to address this.

Thanks,

 Dr.shraddha

 

 

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 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

 

 

 

 

 

Writing Company assessment in pharmacovigilance

 

With changing times, it is said that we have lost a lot of our attention span and this if applied to our reading, makes us to read something quickly and come to conclusion. 

This is exactly what physicians, health authorities, responsible HCP (Healthcare Professionals) want to read when they read adverse event report preferably CIOMS/MedWatch. They just want to get idea regarding the reported adverse event and the suspect drug and what does the company's position is on this.

Medical assessment is known as company comment, sponsor comment, MAH comment and so on  but in this blog we will term it as medical assessment. The medical assessment or sponsor assessment or company comment is exactly the place where you will find this information.

What is medical assessment?

This is short description (generally not more than 4 to 5 sentences) regarding Sponsor's position with respect to the reported Adverse Event (AE) and Sponsor's suspected products and its relationship to AE in a very brief and conclusive way.

Who should write it?

Many Sponsors* and Regulatory authorities* prefer safety physician’s i.e certified medical doctors to  write it especially for Clinical Trials (CT) and Serious cases. However non serious and post marketing adverse event reports can be handled by experienced pharmacovigilance individuals who are not medical doctors per se but are HCP’s with proper training and expertise. In fact, regulatory guidelines are also not stringent regarding requirement of only medical doctors to write medical comment for all cases in PV , and same is being followed widely in industry.

Prerequisites for writing a comprehensive company comment:

     1.    Know the safety profile of drug- Refer to IB,RMP,SmPC,PIL .This helps to understand the mechanism of action and safety profile of suspect product in relation to the reported event.

 2.     Causality assessment- It is a topic, that will be explored in detail in another blog. However the important prerequisite is that causality assessment has to be done so you know your position as to is it a related or not to suspect product. This helps in writing sponsor assessment so that you know how and what to write. 

3.       Know the clinical presentation of the event, it is important to know the disease pathophysiology, risk factors etc so as to explain the event and correlation to drug.

4.     Know the time to onset/Latency (temporal relationship of the event and product).

5.      Knowing safety profile of other concomitant medications. This is not always very easy, especially in patients when conmeds are reported as none or many. The trick is first go by class of drugs and then download the SmPC/PIL/USPI of relevant drugs from company website/RA websites. (You can find such relevant websites on my previous blog)

What and how should it be framed?

Medical assessment is free text field in any Safety database used by Sponsor. Most Sponsors have a standard template to help drafting it.

Some common do’s are:

1.  Use full generic drug names (i.e. for the active ingredients) only; no abbreviations.

2.   If the case is not assessable due to poor documentation, describe what additional information is needed to determine causality. Ensure you send follow up for this missing information.

3.  If required, provide reference of case definitions/literature to support the assessment.

4.  Provide the statement regarding the current safety profile of drug in relation to current RSI and event (listedness).

Some common don’ts are:

1.   Be concise (e.g. do not repeat case demographics which are already mentioned in case narrative i.e age & sex, unless they contribute to the medical assessment).

2.    Avoid abbreviations including obvious one’s as well  e.g COPD,DM,URTI,HB etc .

3.   Do not include calendar dates but the number of days from exposure to event (e.g. 2 Days after treatment started) i.e latency; it is acceptable to give approximate dates (e.g. after about two months or 2 years when more appropriate).

4.    Avoid mentioning unsubstantiated or non-scientific sources to frame sentences.

5.    Avoid using very definitive and specific terms or personal opinions like it is highly impossible, not at all related etc.

6.    Avoid mentioning assessment for other company suspect products when not needed or when data is inconclusive.

Take home message : 

It is important to remember that the medical assessment should make medical and scientific sense and is standardized ( conveying  same meaning to every reader). It is company statement and the writer should remember that it can be challenged during audits/inspections.

*Sponsor/Marketing Authorization Holder/Manufacturer and RA/HA/NRA/CA (Regulatory Authorities/Health Authorities/National Regulatory Authority/Competent Authority) are used interchangeably for ease in blog but have different definition.

 Written by:

Dr.shraddha Bhange.

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Risk Management Plan (RMP)

 The most complicated and tedious document as per me in my PV career is RMP (Risk Management Plan). 

Who requests and why?

An RMP is requested for any medicinal product undergoing a authorisation application by various health agencies e.g. EMA, Japan etc.It is also an requirement to maintain one for medicinal product for its lifecycle.

What is RMP and how it helps?

An RMP serves as a planning document for assessing how the risks identified for a medicinal product would be managed.The RMP serves as document that can discuss about conducting PASS, additional pharmacovigilance activities required for certain risks that need monitoring. An MAH (Marketing Authorisation Holder) should start with dRMP (Developmental Risk Management Plan) once the clinical trials are initiated. Aggregate reports such a DSUR  serves as bridge/link for dRMP . The aggregate analysis done during each review period for DSUR will parallely help in identifying risks during the development of product.

The dRMP then can be drafted to become RMP.  RMP also serve as guidance for drafting SMPC/USPI/PI sections pertaining to safety.

Frequency or timelines of RMP?

RMP is a live document that has no DLP or no specific timelines for update once finalised/submitted. It should be updated on need basis, meaning whenever there is update with respect to any risks or risk minimisation measures identified while writing a aggregate reports, signal detection analysis, ICSR, Literature monitoring etc.

Template:

I have copied the RMP template below from EMA website (reference links below). Most of the health authorities do not have any standard template for RMP. Many MAH follow EU-RMP or REMS (FDA) template and is accepted.

Part I Product(s) overview 

Part II Safety specification 

Module SI Epidemiology of the indication(s) and target population(s) Module SII Non-clinical part of the safety specification 

Module SIII Clinical trial exposure 

Module SIV Populations not studied in clinical trials 

Module SV Post-authorisation experience 

Module SVI Additional EU requirements for the safety specification 

Module SVII Identified and potential risks  

Module SVIII Summary of the safety concerns 

Part III Pharmacovigilance plan (including post-authorisation safety studies)

Part IV Plans for post-authorisation efficacy studies 

Part V Risk minimisation measures (including evaluation of the effectiveness of  risk minimisation activities) 

Part VI Summary of the risk management plan 

Part VII Annexes 

Discussion about template:
The product specification would particularly be aligned with the product details which we can furnish form IB/CCDS/USPI . The part that is particularly tricky is where we need to mention identified ,potential risks and missing information (all definitions in GVP module V). Also it depends on which stage product is in, for a product that is yet to be approved, potential risks and missing information would be more. All other modules are self explanatory, the important one I can highlight is module SVII identified and potential risks which should explain each risk individually, the clinical details of it, diagnosis, treatment available, its severity and effect on population and how MAH will put forth the measures to minimize or prevent it.

It is important that MAH should monitor the outcome of each risk minimization measures that were included and implemented for risks.  If the outcomes or assessment of measures present need of change or additional measures for risks, the RMP should be updated and the measures should be immediately acted upon.

References:

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans

Written by:

Dr.shraddha Bhange.

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Monitoring safety of drugs:Pregnancy and Breastfeeding

 Pharmacovigilance in terms of monitoring safety of drugs in pregnant and breastfeeding mothers is very critical and also different. 

For knowing safety profile of drug during pregnancy or breastfeeding we are dependent on pharmacologic or chemical class of drug, or animal studies or clinical trials data.

Why critical?

1. Almost all clinical trials for registering new drugs exclude pregnant and breastfeeding women. So data is not available regarding effects of drug on this population easily.

2. Special clinical trials and data collection methods are required to monitor effects of drug on this population.

Hence to know safety profile of drugs during pregnancy, post marketing surveillance is major source of data. This is collected after the drug has been approved and used by pregnant women voluntarily when they know they are pregnant or when they used drugs without knowing in advance they were pregnant. 

Usage of drugs during pregnancy and breastfeeding is different than when used in general population for 2 reasons:

1. Use of drugs has to be thought in terms of its risks and benefits to mother and child both.

2. Risk of disease if left untreated without administering drug has to be weighed for both mother and child.

E.g. if breastfeeding is continued to benefit baby, is the risk greater to infant from receiving milk with drug excreted from mother in it or the mother's disease left untreated pose more risk in terms of quality of milk?

ICSR:

The route of administration in baby case (ICSR) is transplacental/transmammary and event is exposure in utero/Drug exposure via breast milk . The route of administration for the mother case is to be coded in correct fields in parent/child section .The outcome and event coding should correlate to correct patient i.e. baby and parent. 

Some important fields for cases are: Gestational age, Ultrasound results (in narrative), Use of other drugs especially teratogens, Outcome of pregnancy.It is also important to link cases.

It is also critical to know when to create 2 cases i.e. parent and child and when only 1 i.e. parent. The key to remember is usually if there is an adverse event for baby then 2 cases and if no adverse event then on;y 1 i.e. parent case. E.G.

1.  A pregnant women with abortion then only 1 case of mother with event abortion. However if its full term pregnancy and foetal death is outcome then 2 cases.

2. A pregnant women delivered baby with foetal abnormality then 2 cases baby and mother.

Expedited reporting of cases (parent and baby) follows same timelines. Cases with no adverse event or non serious preganancy cases, cases with termination of pregnancy are usually reported in PSURs/PBRER's.

Aggregate reports: 

PBRER/PSUR for product the frequency and template remains same for the drug concerned. The additional data to be included about drug use in pregnancy and breastfeeding should be described in relevant sections. The data sources is the ICSR received from spontaneous source, literature, pregnancy registries, studies etc where an pregnancy or breastfeeding exposure is reported with or without adverse pregnancy outcome.

Another additional section is drug utilisation by age group wherein it should be monitored if reproductive age group patients were exposed to the product to have data regarding quantitative exposure for this group.

The risk/benefit section should describe the cases of pregnancy and breastfeeding exposure and its relevance to safety profile of drug. If pregnancy and breastfeeding exposure is one of the safety concern in RMP then its important to mention the data relating to it in detail especially what is status of risk minimisation measures already implemented or if planned.

It is important to mention pregnancy/breastfeeding exposure as missing information in RMP and to monitor it.

Pregnancy registries: 

Different types of registries are maintained wherein data is collected regarding women who have been exposed to drugs during pregnancy and for drugs with longer half life's before pregnancy, male exposed to such drugs where pregnancy occurs following it, birth registers, birth defect registries etc.

When studied appropriately they provide very useful information in generating signal or at least signal hypothesis.

Studies conducted to study pregnancy and breastfeeding exposure and data collected from it. This study should be planned in structured manner and outcomes to be collected with longer follow ups (6-12 months at least after pregnancy period and include baby follow up too).

References:

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-product-population-specific-considerations-iii_en.pdf

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-exposure-medicinal-products-during-pregnancy-need-post-authorisation-data_en.pdf

https://www.ncbi.nlm.nih.gov/books/NBK208605/

https://www.fda.gov/science-research/womens-health-research/list-pregnancy-exposure-registries

Written by:

Dr.shraddha Bhange.

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Basics learnings from MDR (Medical Device Regulation)

Recently while discussing with colleague regarding device regulations, I realized much is not know about this topics. And decided to share my learnings via my blog to open a dialogue and learn more.

1.       What is medical device?

It is any instrument which is used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation of disease ,injury or disability. Primarily it is an agent which does not alter or work on  pharmacological, immunological or metabolic systems of human body, but which assists this systems in its function.

Let's look at key points mentioned in EU-MDR for monitoring safety of medical devices (European Union's Medical Device Regulation document).

What is combination product?

21 CFR 3.2 (e) Definitions

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device, device and biological, or biological and drug product. [single entity]

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use. [cross-labeled ]

·        1.  Reporting post market surveillance of serious incidents and field safety corrective actions through the electronic system:            

•  any serious incident involving devices made available in EU, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation
•  any field safety corrective action in respect of devices made available in EU (includes actions from third country if the reason for the field safety corrective action is not limited to the device made available in the third country).
• All serious related incidents no later than 15 days after MAH (Marketing Authorisation Holder*) become aware of the incident.
• All serious related incident which pose serious public threat no later than 2 days after MAH become aware of the incident.
• Serious related death incident, no later than 10 days after MAH become aware of the incident.
• Inform field safety corrective actions in same timeframe as above before implementing them except in case of urgency when it can be notified after implementing.
• Serious incidents and field safety corrective action which are identified and documented or a implemented and are common they may be submitted as periodic summary reports instead of individual serious incident reports, after consultation with the competent authorities.

HiHighlight:       

      MDRs are required when a manufacturer (or representative) becomes aware of information that reasonably suggests that their marketed medical device has or may have caused or contributed to a death, serious injury, or has malfunctioned and likely to cause or contribute to a death or serious injury if malfunction were to recur.

MDR Report Requirements:

5-Day MDR Report, described in 21 CFR 803.53(a), which requires a MDR to be filed no later than five business days following the occurrence of an event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health

30-Day Device Malfunction Report, described in 21 CFR 803.20(b)(3)(ii), which must be filed no later than 30 days after receipt of a report of the malfunction of a device; this requirement applies only to certain permanently implantable, life-supporting or life-sustaining  medical devices

 

2.  Recording and reporting of adverse events that occur during clinical investigations:

             The sponsor shall fully record all of the following:

• adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
• any serious adverse event;
• any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
•  any new findings in relation to any event referred above.

3. Other documents required:

• Post market surveillance plan (PMCF) is necessary except for custom-made device and is part of technical documentation.
• Clinical evaluation report is required
• PSUR required for class IIa, class IIb and class III devices. For class IIb and class III devices update the PSUR at least annually. For class IIa devices update the PSUR when necessary and at least every two years. For class III devices or implantable devices, submit PSURs as specificed with other assessment documentation during registration. For devices other than mentioned, PSURs should be made available upon request of competent authorities (CA).
• Trend analysis is required: any statistically significant increase in frequency or severity of non serious or listed side effects that can alter benefit-risk analysis. The MAH should inform such to competent authorities and also mention how to manage it.
•   Field safety notices: Report containing UDI,SRN and field safety corrective action prepared by MAH and submitted to HCP and users after approval form CA.
• RMP ( risk management plan) for each device is required.
• For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (equivalent to SmPC) to the public via Eudamed. This document should have UDI-DI and SRN if available other content remains same as of SmPC for drugs. This document should be made available on Eudamed (European database on medical devices).
• .   * Also include manufacturer/distributors.

4. Terminologies and requirements:

•   Having a Unique Device Identification (UDI) system in place which allows to trace the device throughout the system.The UDI shall be used for reporting serious incidents and field safety corrective actions .
•    SRN (Single Registration Number) generated from electronic database by Competent Authority  while registering device for MAH
• Eudamed is used for maintaining registration, manufacturer details,clinical investigation,certificates,pharmaocivgilance etc by Member States, notified bodies, economic operators and sponsor.
• ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect
• ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:

  (a)the death of a patient, user or other person,

 (b)the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,

(c)a serious public health threat;

(d) any of the above

5.   Regulatory representative:

•   a diploma, certificate or other evidence of formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
•   four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
•   at least two years of professional experience within a relevant field of manufacturing.
•   Micro and small companies do need to have this person within their organisation but have a person on contract permanently and continuously at their disposal.

References:

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=IT#d1e1058-1-1

Written by:

Dr.shraddha Bhange.

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

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