Discover the course

Pharmacovigilance Oversight

How to guarantee quality and to manage pharmacovigilance audits and inspections succesfully in PV oversight activities

Date

29 September 2020

Location

Amsterdam

Language

English

Pharmacovigilance Oversight

The implementation of an effective pharmacovigilance function is high on the list of priorities for pharmaceutical companies. Pharmacovigilance management is a regulatory obligation for all companies holding an Authorization into Commerce (AIC) or an Authorization for Production (AP). Updates and legislative obligations on pharmacovigilance have significantly increased, making the management of related processes complex and expensive for the pharmaceutical company.
Therefore, resorting to outsourcing certain processes or pharmacovigilance services may be a solution. Managing third parties naturally requires oversight by the AIC holder, as well as implementation and management of adequate supporting documentation, so that the process can be under control and be reliable. In particular, the management of third parties can envisage a diversified approach according to the authorization procedure of the pharmaceutical product, and thus foreseeing different types and levels of responsibilities for the third parties involved.

The course will address:

  • The key aspects related to audits of service providers by the marketing-authorisation holders (MAHs) or regulatory authority inspections
  • What makes a successfully run audit or inspection regardless of the findings
  • Practical information and advice on service provider activities
  • The keys to preparing for and effectively managing audits and/or inspections, as well as gaining insight into the roles and expectations of key functions

The training course will cover the following aspects:

  • Brief analysis of the legislation in force
  • Oversight vendor concept, including the use of key performance indicators (KPIs)
  • Practical information and advice on service provider activities
  • Implementation of a correct oversight of the third parties SDEA
  • Analysis of the contractual structure
  • Key aspects related to audits
  • Key aspects related to inspections by Regulatory Authorities


Course Language

The course will be in English

Parminder Kaur
Parminder Kaur CEO & EU QPPV at RegPak BioPharma Consulting

Parminder Kaur is the owner of RegPak BioPharma Consulting based in Amsterdam, The Netherlands and Bucharest, Romania.  RegPak provides consulting services in regulatory affairs and pharmacovigilance domain and as of 2019 started medical device CRO too. 

She has played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies; assisted various companies during Inspections and Audits conducted by EU Regulatory Authorities. 

Parminder has received many International awards for her expertise and continuous efforts in promoting knowledge via educational programmes.

Parminder had been a speaker, panellist and Masterclass provider at various international conferences. 


This course is intended for all those who are involved in third-party management in pharmacovigilance (responsible for pharmacovigilance, Quality Assurance, Regulatory, Legal, Procurement) in BioPharmaceutical companies, Medical device companies, PV Service Providers and PV Consultants/Contractors.

Lectures, discussions, and practical exercises

The course will take place in Amsterdam


Upon Arrival
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.

Refreshments
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.

Limited number of participants to encourage networking and discussion.



Training Room

All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.



Teaching materials

All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Brochure
Certificate of attendance

Early Bird: € 880,00* (until 01 September 2020)

Ordinary: € 990,00*

Freelance - Academy - Public Administration**: € 490,00*


* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance - Academy - Public Administration fee


The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.

Register now

Course Price

990.00 €

Early Bird

Tuesday, September 1, 2020

890.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Understand the importance of key performance indicators (KPIs) within the PV organisation

  • Learn the pharmacovigilance inspections and key PV activities

  • Ensure compliance with assessments of risk and CAPA and preventative actions

  • Understand the processes/activities/documentation that needs to be reviewed and how to set up its logistics accordingly

  • Learn practical tips to be used on a daily basis

Participants' Feedbacks

I was put at ease during the course and the discussions

Teachers very expert and very good in comunication

LS Academy secretariat available to facilitate enrollment of more than one person from the same company

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

Information collection and use
In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.