Training
'Atessia Master Class'
Atessia offers you tailormade intra-company training courses on the following themes or at your request on a specific subject.
Regulation of promotional and non-promotional information
- Health product advertising
- Drug advertising: the promotional/non-promotional boundary
- Clinical studies in advertising
- Advertising medicines to healthcare professionals
- Advertising medicines to the general public
- The role of non-promotional staff in contact with healthcare professionals
- Digital communication
- Managing your relations with the press
- MSL communication
- Certification of canvassing activities for the promotion of medicinal products
- Media planning: the impact of healthcare product regulations
- …
Quality system of the Exploitant & CMC - Chemistry, Manufacturing and Controls -
- Controlling the Exploitant’s assessment of a Product Quality Review (PQR)
- Claims
- ICH Q12 : Opportunities and feasibility of CMC change management
- Nitrosamines: regulatory aspects and update
- Data integrity in the eCTD
- Module 3 of the MA dossier
- eCTD environment
- The “Common Technical Document” module 3 and pharmaceutical variations
- …
Pharmacovigilance
- Updated good pharmacovigilance practices
- Additional option: analysis of pharmacovigilance inspection feedback
- Focus on the Pharmacovigilance System Master File (PSMF)
- Managing post-marketing pharmacovigilance cases
- Signal detection: concepts
- PSUR
- Risk Management Plan (RMP) in pharmacovigilance
- The pharmacovigilance quality system
- …
Registration
- The different types of drug registration procedures and the legal basis for Marketing Authorization (MA) applications
- Application of the European “Variations” regulation to MAs – medicines for human use
- Exceptional access in France: early access and compassionate use
- …
Medical device
- Medical Devices (European regulation, distributor responsibilities)
- Advertising for medical devices aimed at patients – Regulatory aspects, focus on “practical implementation”
- Materiovigilance
- …
Tailormade at your request!
75% of trainees for the year 2023 and 89,5% of trainees for the first half of 2024 gave a satisfaction rating of 4 stars and above.
Result based on a 5 star rating scale.
ATESSIA has been QUALIOPI certified for training activities since 13 December 2021. This is a unique quality certification issued by independent certifiers, allowing the use of public or mutualised funds.
Atessia is certified “Digital enrolment by Edusign”. Solution for the digitalization of training registration forms.