TO BE AUDITED OR INSPECTED – A practical pharmacovigilance training

FULL DAY IN-PERSON TRAINING+ 1 HOUR PERSONALIZED CONSULTATION, 17 OCTOBER 2023

Description:   

To be audited and inspected is something everyone working within Pharmacovigilance will be exposed to, at one point or another. In this situation, it is all about being able to present your company's PV system in a way that shows that patient safety is ensured at your company, and how you do it. So how can we build the skills and confidence to do that?

As we see it, audit and inspection readiness is all about being both mentally and practically prepared.

This is why our PV experts have developed this interactive training, where you practice real-life situations relevant to your own role. You will get the opportunity to explore different scenarios of the pre-audit/inspection and conduct, in a safe and calm setting. Our trainers Lena and Ann-Marie have experience in roles as auditor and inspector. They have also been in the situation of being audited and inspected. By sharing their experience and competence they will guide you through the training day's exercises.

What you will learn, and why you would want to learn it?

Practice presenting your area of expertise and see what works well and what works less well. Get feedback including examples of requests within your area.
Understand what you can prepare and do to be more audit/inspection ready, both mentally and practically.
How to assess your gaps/deviations in advance in order to be proactive and prepared.
Critical considerations when replying to audit/inspection requests.
Understand why the auditor/inspector requests specific items, what they are looking for, and how they are using the information.
Understand what an inspector/auditor expects and how they work, by putting yourself in their situation.

Target group:   

You work with or together with Pharmacovigilance and Drug Safety at a headquarter or affiliate.

You are a vendor/service provider. You want the PV-audit situation to be less stressful. You might feel practically prepared but never had the chance to practice the actual conducting parts.

Course set up:

Preparation before the session: You will be provided with pre-read material on audits and inspection definitions, such as the audit universe, legal requirements, audit types, audit strategy and program, and different roles in an audit/inspection. You are asked to prepare a 5-minute presentation of your PV area, to practice this element in a small group. Finally, an optional task consists of collating certain data in advance of the course, which will be discussed during the course. Make sure to set aside time for preparations in advance of the course. Estimate two hours, depending on your previous experience and knowledge. More detailed instructions will be sent out well in advance.

During the session: We are using a dynamic approach in our training, with practical exercises, alongside discussions on what this means in practice. You will also receive useful materials to help you apply your learnings back in your office.

After the session: The 1-hour personalized consultation is the perfect complement to this training. Our PV team will join you digitally or physically to discuss current issues or how to apply the learnings you obtained during the sessions in your own organization. Maybe you need strategic PV advice or, if you are new or alone in your PV role, you might rather prefer an hour of mentoring with a PV-expert. Contact us within 15 days after the on-site training to schedule this personalized 1-hour session.

Short agenda:

9.30 -10.00 Optional meet and greet trainers and participants (coffee)
10.00-12.00 Workshop focus: Audit/Inspection Preparation /Readiness
12.00-13.00 Lunch
13.00-16:45 Workshop focus: Audit/Inspection conduct
16.45-17.15 Optional meet and greet PharmaRelations (Sandwich)

Download the full invitation

Date: 17 October 2023

Time: 10:00 -16:45 + 1 hour ad-hoc consultation

Language: Swedish  

Location: Frösundaviks Allé 1, Stockholm, Sweden   

Standard fee: 6.900 SEK (exc. VAT)

The fee includes Pre-read materials, templates and handouts, a course certificate, lunch, and coffee/refreshments.  

Groups of 4 or more people will obtain a special price.  

Meet the trainers

Lena Ternrud has more than 4 years of experience from competent authorities as a Pharmacovigilance Inspector at the MPA. She has worked 14 years with Pharmacovigilance, and her previous experience also includes medical information, regulatory affairs, and quality assurance.

Ann-Marie Hjemgaard has extensive knowledge and experience of pharmacovigilance processes from working 22 years in different PV roles within the pharmaceutical industry. She also has extensive knowledge and experience in Computer System Validation (CSV) of GxP PV systems, data integrity, and data privacy.

Both Lena and Ann-Marie work as Senior Pharmacovigilance experts at PharmaRelations, where they perform PV and CSV audits as well as QPPV and Deputy QPPV assignments.

Contact Contact concerning the course content

Do you want to build skills and confidence to lead yourself and your organization through a PV audit or inspection?

Register today to secure your spot!

Terms & conditions

Registration is binding and when you have received our confirmation the following conditions are known and accepted.

Registration is irrevocable but not personal. If you are unable to attend, substitution with a colleague from the same company is possible.

Confirmation:

A confirmation will be sent to you by e-mail within 5 working days after your registration.

Payment

An invoice will be sent to you after your booking has been confirmed. Payment terms are 20 Days.

Participation fee and VAT

All prices and participation fees are per person and excluding VAT.

Cancellation and change of event date from the organizer PharmaRelations

PharmaRelations owns the right to cancel or change the dates of an event. In such a case, you will be refunded the full participation fee. We do not reimburse any other costs you may have had in conjunction with the cancellation.