basi normative della necessità di un adeguata formazione · • there should be a process in place...

Basi normative della necessità di un’adeguata formazione

Laboratorio di Qualità in Farmacovigilanza 124 Ottobre 2017

Perché il Training?

Necessità che tutte le Persone coinvolte – a qualunque titolo –nella Farmacovigilanza conoscano la Normativa

La Normativa prevede che il training sia erogato

Le SOP introducono il training previsto nella Normativa nella usuale attività


GVP – Find Train

Module I - Pharmacovigilance systems and their quality systems Module II - Pharmacovigilance system master file Module III - Pharmacovigilance inspectionsModule IV - Pharmacovigilance audits (Rev. 1) Module V - Risk management systemsModule VI - Management and reporting of adverse reactions to medicinal products Module VII - Periodic safety update report Module IX - Signal management


Module I - Pharmacovigilance systems and their quality systems

I.B.6. Responsibilities for the quality system within an organisationA sufficient number of competent and appropriately qualified and trained personnel shall be available for the performance of pharmacovigilance activities [IR Art 10(1), Art 14(1)]. Their responsibility should include adherence to the principles defined in I.B.5.

For the purpose of a systematic approach towards quality in accordance with the quality cycle (see I.B.3.), managerial staff (i.e. staff with management responsibilities) in any organisation should be responsible for: omissis

• ensuring that adequate resources are available and that training is provided (see I.B.7.);



I.B.7. Training of personnel for pharmacovigilance

• All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)]. For Marketing Authorisation Holders, this training shall relate to the roles and responsibilities of the personnel [IR Art 10(3)].

• The organisation shall keep training plans and records for documenting, maintaining and developing the competences of personnel [IR Art 10(3), Art 14(2)]. Training plans should be based on training needs assessment and should be subject to monitoring.

• The training should support continuous improvement of relevant skills, the application of scientific progress and professional development and ensure that staff members have the appropriate qualifications, understanding of relevant pharmacovigilance requirements as well as experience for the assigned tasks and responsibilities. All staff members of the organisationshould receive and be able to seek information about what to do if they become aware of a safety concern.

• There should be a process in place within the organisation to check that training results in the appropriate levels of understanding and conduct of pharmacovigilance activities for the assigned tasks and responsibilities, or to identify unmet training needs, in line with professional development plans agreed for the organisations as well as the individual staff members.



I.B.7. Training of personnel for pharmacovigilance

• Adequate training should also be considered by the organisation for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance. Such activities include but are not limited to those related to clinical trials, technical product complaints, medical information, terminologies, sales and marketing, regulatory affairs, legal affairs and audits.

• Appropriate instructions on the processes to be used in case of urgency, including business continuity (see I.B.11.3.), shall be provided by the organisation to their personnel [IR Art 10(4), Art 14(3)].



I.B.11. Documentation of the quality system All elements, requirements and provisions adopted for the quality system shall be documented in a systematic andorderly manner in the form of written policies and procedures, such as quality plans, quality manuals andquality records [IR Art 8(4)].

A quality plan documents the setting of quality objectives and sets out the processes to be implemented to achievethem. A procedure is a specified way to carry out a process and may take the format of a standard operatingprocedure and other work instruction or quality manual. A quality manual documents the scope of the qualitysystem, the processes of the quality system and the interaction between the two. A quality record is a documentstating results achieved or providing evidence of activities performed.

omissis

The quality system shall be documented by:

• documents on organisational structures and assignments of tasks to personnel (see I.B.11.1. and I.B.11.2.);

• training plans and records (see I.B.7.) [IR Art 10(3), Art 14(2)];

• instructions for the compliance management processes (see I.B.9.) [IR Art 11(1), Art 15(1)];

• appropriate instructions on the processes to be used in case of urgency, including business continuity (seeI.B.11.3.) [IR Art 10(4), Art 14(3)];

• performance indicators where they are used to continuously monitor the good performance ofpharmacovigilance activities [IR Art 9(1)];

• reports of quality audits and follow-up audits, including their dates and results [IR Art 13(2), Art 17(2)].

Training plans and records shall be kept and made available for audit and inspection [IR Art 10(3), Art 14(2)].


I.C.1.2. Qualifications of the qualified person responsible for pharmacovigilance in the EU The Marketing Authorisation Holder shall ensure that the QPPV has acquired adequatetheoretical and practical knowledge for the performance of pharmacovigilance activities[IR Art 10(1)]. The QPPV should have skills for the management of pharmacovigilancesystems as well as expertise or access to expertise in relevant areas such as medicine,pharmaceutical sciences as well as epidemiology and biostatistics. Where the QPPV hasnot completed basic medical training in accordance with Article 24 of Directive2005/36/EC, the marketing authorisation holder shall ensure that the QPPV is assisted bya medically trained person (i.e. in accordance with Article 24 of Directive 2005/36/EC)and this assistance shall be duly documented [IR Art 10(1)].The expectation is that the applicant or marketing authorisation holder will assess thequalification of the QPPV prior to appointment by, for example, reviewing universityqualifications, knowledge of EU pharmacovigilance requirements and experience inpharmacovigilance.The applicant or marketing authorisation holder should provide the QPPV with trainingin relation to its pharmacovigilance system, which is appropriate for the role prior tothe QPPV taking up the position and which is appropriately documented. Considerationshould be given to additional training, as needed, of the QPPV in the medicinal productscovered by the pharmacovigilance system.


I.C.1.3. Role of the qualified person responsible for pharmacovigilance in the EU

Omissis

This responsibility for the pharmacovigilance system means that the QPPV has oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).


Module IV - Pharmacovigilance auditsIV.B.2.1.Strategic level audit planningOmissisThis is a non-prioritised, non-exhaustive list of examples of risk factors that could be considered for the purposes of a risk assessment:Omissisrisk to availability of adequately trained and experienced pharmacovigilance staff, e.g.

due to significant turn-over of staff, deficiencies in training processes, re-organisation, increase in volumes of work;

IV.B.3.1.2. Qualifications, skills and experience of auditors and continuing professional development Auditors should demonstrate and maintain proficiency in terms of the knowledge, skills and abilities required to effectively conduct and/or participate in pharmacovigilance audit activities. The proficiency of audit team members will have been gained through a combination of education, work experience and training and, as a team, should cover knowledge, skills and abilities in: audit principles, procedures and techniques; applicable laws, regulations and other requirements relevant to pharmacovigilance; pharmacovigilance activities, processes and system(s); management system(s); organisational system(s).

Module V - Risk management systems

V.B.3.1. Marketing Authorisation Holders and applicants

Omissis

The design of risk minimisation activities should involve people with expertise in communication and, where appropriate, patients and/or healthcare professionals. Since a risk management plan is primarily a pharmacovigilance document, ideally the production of it should be managed by personnel with appropriate pharmacovigilance training in either the pharmacovigilance or regulatory departments, depending upon company structure.


Module VI - Management and reporting of adverse reactions to medicinal products

VI.B.5. Quality managementOmissis• Staff directly performing pharmacovigilance activities, should be

appropriately trained in applicable pharmacovigilance legislation and guidelines in addition to specific training in report processing activities for which they are responsible and/or undertake. Other personnel who may receive or process safety reports (e.g. clinical development, sales, medical information, legal, quality control) should be trained in adverse event collection and reporting in accordance with internal policies and procedures.

VI. App2.6 Review and selection of articles • It is recognised that literature search results are a surrogate for the actual

article. Therefore, it is expected that the person reviewing the results of a search is trained to identify the articles of relevance. This may be an information professional trained in pharmacovigilance or a pharmacovigilance professional with knowledge of the database used.


Module VII - Periodic safety update report

VII.B.7. Training of staff members related to the PSUR process • For all organisations, it is the responsibility of the person responsible for

the pharmacovigilance system to ensure that the personnel, including pharmacovigilance, medical and quality personnel involved in the preparation, review, quality control, submission and assessment of PSURs are adequately qualified, experienced and trained according to the applicable guidelines (e.g. ICH E2C(R2) and this GVP Module VII).When appropriate, specific training for the different processes, tasks and responsibilities relating to the PSUR should be in place.

• Training to update knowledge and skills should also take place as necessary.

• Training should cover legislation, guidelines, scientific evaluation and written procedures related to the PSUR process. Training records should demonstrate that the relevant training was delivered prior to performing PSUR-related activities.


Module IX - Signal management

IX.B.4.2. Quality systems and documentation

An essential feature of a signal management system is that it is clearly documented to ensure that the system functions properly and effectively, that the roles, responsibilities and required tasks are standardised, that these tasks are conducted by people with appropriate expertise and are clear to all parties involved and that there is provision for appropriate control and, when needed, improvement of the system.

Omissis

Staff should be specifically trained in signal management activities in accordance with their roles and responsibilities. The training system and location of the training records should be documented, and curricula vitae and job descriptions should be archived.


COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012

Sec t i o n 2 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by Marketing Authorization HoldersArticle 10 Management of human resources 1. The Marketing Authorisation Holder shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities. For the purposes of the first subparagraph, the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities. Where the qualified person has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (1), the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person. This assistance shall be duly documented. 2. The duties of the managerial and supervisory staff, including the qualified person responsible for pharmacovigilance, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisational chart. The marketing authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorisation holder. 3. All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training in relation to their role and responsibilities. The marketing authorisation holder shall keep training plans and records for documenting, maintaining and developing the competences of personnel and make them available for audit or inspection. 4. The Marketing Authorisation Holder shall provide appropriate instructions on the processes to be used in case of urgency, including business continuity.

DM Lorenzin attuazione DIR/2010/84/UE e DIR/2012/26/UE

ART. 17.(Disposizioni concernenti il titolare dell'AIC)

Omissis4. Nell'ambito del Sistema di Farmacovigilanza il titolare dell'autorizzazione deve:a) disporre a titolo stabile e continuativo di una persona adeguatamentequalificata, responsabile della farmacovigilanza con documentata esperienza intutti gli aspetti di farmacovigilanza, fatte salve le situazioni regolarmente in attoalla data di entrata in vigore del presente decreto;omissis6. Fatte salve le disposizioni del comma 4, l'AlFA può chiedere la nomina di unapersona di contatto per le questioni di farmacovigilanza a livello nazionale la qualeriferisca alla persona qualificata responsabile della farmacovigilanza. La persona dicontatto per le questioni di farmacovigilanza a livello nazionale, o in sua assenza lapersona adeguatamente qualificata responsabile della Farmacovigilanza, provvedea registrarsi alla Rete Nazionale di Farmacovigilanza.


Training: a chi?

• A tutti i Dipendenti Aziendali – Oltre ai DipendentiInsoliti/Atipici:

• [in genere a persone che possono ricevere telefonate ocorrispondenza dall’esterno]

• Reception (anche Guardia Giurata)• Consulenti che hanno mansioni in Azienda• Telefonisti in Remoto• Clinical Operations delle Sperimentazioni Cliniche• Sperimentatori di Studi Locali (Interventistici e non)• Ricerche di Letteratura, Medical Information, CustomerCare in Outsourcing• Agenzie per le Ricerche di Mercato• Persone dello Stabilimento Produttivo (Centralino,Responsabili della Produzione, Regolatorio, Direttore, etc.)


Training: come si differenzia/1?

Training di IngressoTraining AnnualeTraining per Cambio Ruolo / Assenze ProlungateTraining per l’aggiornamento della NormativaI cosiddetti Training per «motivi specifici»Training per Customer Care (Provider)Training per Distributori, Concessionari, PartnerCommercialiTraining sul Sistema di Gestione della Qualità


Training: come si differenzia/2?

Parte generale

- Cos’è la FV- Perché la FV- Concetto di ADR- Dove si nasconde una possibile ADR

Parte specifica legata al ruolo

- Si incentra sulla seguente domanda: come la FV può interagire col mio ruolo?

- Come ogni contatto con persone esterne può fornire informazioni di safety


Training: come ricavo le specificità del ruolo?

• Dalla propria esperienza• Dal diretto Superiore della persona da sottoporre al training• Dall’incontro con le Risorse Umane• Dall’incontro col diretto interessato• Creazione della Matrice dei Ruoli


I Training «Motivo Specifici»

[Diversità tra le Aziende, con la partecipazione di FV/Regolatorio/Direzione Medica/Direzione Marketing/Trainer Scientifico]

• Training sul Risk Management Plan (RMP)• Training su Dear Healthcare Professional Communication - DHPC• Training sugli aggiornamenti dell’RCP (paragrafo 4.x)• Presentazione della safety del prodotto al momento del lancio• Business Continuity Plan (BCP)• Materiale Educazionale• Training su Audit / Ispezioni• Training a seguito di Non Conformità


Training: sistema di gestione della Qualità

Conoscenza del Sistema di gestione qualità Aziendale

Necessario:• Training sul Sistema di gestione della Documentazione• Training sulle SOP del SGQ (es. training, audit

interni..)• Training sulla gestione delle Non Conformità• Training sul CAPA Systhem


Training: come ottimizzare il training?

Ogni modalità può essere utile:

• Vis à vis nel Training di Introduzione all’Azienda• Attraverso modalità in remoto (per e. per i ClinicalMonitors)• Attraverso modalità e -learning• In Riunione Plenaria durante le ConventionAziendali• Attraverso e-mail dopo l’invio di una specifica NotaInformativa


Training: come ottimizzarlo?

Sfruttare ogni occasione!

• Training a gruppi omogenei (Medical Affairs + P. M.,Dirigenti, Segretarie delle diverse Funzioni)• Convention Aziendali• Trovare argomenti differenti e relativi alla Cultura dellaFV (errori medici)• Chiedere la partecipazione alle attività locali deiteams/équipes: riunioni di ciclo, di area, etc : basta un’oradi training!• Programmare gli interventi all’inizio dell’anno• Non essere eccessivamente severi, ma diventarlo pocoper volta


Training: come gestirlo?

Richiesto: Sistema informatico capace di informare ilDipendente• Credenziali per effettuare il training• Test di immediata valutazione• Tracciatura del training effettuato• Rilascio dell’attestato

Necessario:• Database con nome Dipendente, data di assunzione,

data di training• Condivisione con Ufficio Risorse Umane (?)• Almeno la password per l’accesso• Tracciatura degli inserimenti• Inserimento di note per cambio di attività


Training: cosa non si deve fare?

• Rimandare a tempi migliori! Non arriveranno mai• Non informare i superiori del tempo impiegato neltraining• Essere precipitosi!• Non informare il G.M. delle carenze di training e nonprogrammare gli interventi all’inizio dell’anno• Essere eccessivamente arrendevoli nei confronti dellaPersona da formare


Training: chi lo effettua?

• Dipende dall’organizzazione dell’Azienda: può esistereun Trainer o persone dedicate (Train the Trainer)• Persona dell’Ufficio di Farmacovigilanza e Personadell’Ufficio della Qualità• Persona Esterna all’Azienda che si interfaccia con lediverse funzioni


Training: come pianificarlo?

• Organigramma generale

ISTRUZIONE ESPERIENZA FORMAZIONE E SPECIFIC TRAININGDI LAVORO ADDESTRAMENTO

INITIALQUALIFICATION

CONTINUOSQUALIFICATION



• Matrice dei ruoli

• Tipo trainingCorsi da ripetere annualmenteNecessità formative emerse da autovalutazione (es IDP=Individual Development Plan)

• Risk Assessment

Role Training Module How long Type of trainingFrequency for re-training?

Personnel working with the processAll employees involved in PhVDistributorsMedical Information

Training Title 30 minutes2 hours

InductionGxP/Quality systemJob training

N/A3 yearlywith version updates



• Risk Assessment:- risultanze degli audit interni ed esterni e delle ispezioni,- carenze formative evidenziate da non conformità/deviazioni,- carenze nel rispetto delle procedure interne,- aggiornamenti normativi o emissioni di nuovi regolamenti/normative applicabili all’azienda (GVP, ISO, direttive e regolamenti europei ecc.),- cambiamenti significativi introdotti in azienda (nuovi prodotti, riorganizzazione del personale, ecc.).



Risk AssessmentQUESITO Yes/No EVIDENZE TRAINING

EFFETTUATO? (si/no)

DA PIANIFICARE

Dalle risultanze di audit interni si rende necessario effettuare sessioni di training?

Dalle risultanze di audit esterni si rende necessario effettuare sessioni di training?

Dalle risultanze di ispezioni si rende necessario effettuare sessioni di training?

La gestione di non conformità ha evidenziato carenze formative?

Nel corso dell’anno precedente si sono evidenziate carenze rispetto a procedure interne che richiedono un ri-addestramento del personale?

Sono previsti o emessi aggiornamenti normativi (GVP, ISO direttive..) che richiedono un addestramento del personale aziendale?

Nel corso dell’ultimo anno vi è stata riorganizzazione del personale da richiedere addestramento?Nel corso dell’ultimo anno ci sono stati cambiamenti significativi introdotti in azienda che richiedono addestramento specifico (quali?)



Monte ore• Da valutarsi separatamente dal Training di Introduzione• Monte ore minimo suggerito per funzione aziendale• Personale di farmacovigilanza: n giornate da Ente

/Consulente esterno• KPI:

– esempio: Completamento corsi pianificati nelle tempistiche stabilite

– esempio: Ore formazione / ore lavorate %• Es farmacovigilanza 1,5% training


Training Plan

• Chi lo prepara• Periodo di riferimento (annuale)• Firme di approvazione (Managment)• Edizione e data di approvazione• Motivo delle modifiche


Training Plan

TO WHOM TOPIC BY WHO Planned Date Effective Date

1 PhV personnel(name and function)

SOPs, Pharmacovigilanceregulation, WI, internal policy

Local SOP

Training on the job (specificfor the role)

Re-training

2 New company employees

Introduction to PhV

3 All company employees

Refresh and update

4 Relevant company employees and other local partner

Relevant PhV Topic


Training: come documentarlo?

• Agenda del training e Destinatari• Copia del materiale di training (per es. diapositive

presentate con numero progressivo di versione e data)• Training Record con Nominativo, Funzione, Firma,

Data, Nome del Trainer• Foglio della domande/risposte e valutazioni in originale• Copia dell’Attestato di Partecipazione (se applicabile)• PV: Database con tutti i training effettuati• Risorse umane• Personal Training Folder

Tutto il materiale deve essere archiviato per essere rapidamente presentato in caso di audit e di ispezione


Training: Valutazione efficacia

• Questionario di valutazione che è distribuito al terminedel corso (verifica dell’apprendimento) o dopo un periododi tempo dall’effettiva somministrazione dello stesso(valutazione dell’efficacia).La valutazione dei questionari è effettuata dal docente del

corso che assegna una valutazione quantitativa• Un giudizio del responsabile.• Una verifica delle conoscenze acquisite da parte delpersonale addestrato durante lo svolgimento del corsorelativo alle proprie mansioni (prova in campo).


Buon training a Tutti!

Grazie a Matteo per la collaborazione

basi normative della necessità di un adeguata formazione · • there should be a process in place...

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