Authorisation for the organisation of Pharmaceutical Conferences and Meetings

Pharmaceutical companies are more and more oriented to organize training and scientific events, conferences, conventions, and meetings to promote the knowledge, update and training of healthcare professionals.
However, the organisation of these events is not free from regulating obligations, in particular when it comes to events linked to the promotion of medicinal products manufactured or marketed by the same company.
Actually, the Italian law establishes specific procedures to ensure events’ transparency and integrity, preventing conflicts of interest and protecting the quality of the disseminated information.
If your company intends to organize a scientific conference or meeting, in Italy as well as abroad, regarding topics related to their medicinal products, a preliminary authorization must be applied from the Italian Medicine Agency (AIFA).
The authorisation application must be submitted at least sixty days before the date of beginning of the concerned event, as provided for by article 124 of Legislative Decree 219/06, the Italian Code regulating medicinal products.
The Procedure for Obtaining Authorization
We will provide here an overview of the procedures to be followed, the obligations to be complied with, and how to obtain this authorisation correctly and timely.
Request of authorisation to AIFA
Every company organising a conference or a meeting on topics pertaining their medicinal products shall send an authorisation application to AIFA. The request has to be validated within sixty days from the date of the beginning of the events. The application authorisation has to report a series of detailed information, including:
- The event description: topic, format, duration and place;
- Training and scientific goals;
- Event programme, with the list of speakers and of the scientific sessions scheduled,
- Indication of the invited health professionals;
- How the event is sponsored and funded;
Moreover, the Company shall enclose in the application the so called POL (Pagamento Online, online payment), i.e. the economic fee to be paid to AIFA as well as to the Ministry of Health.
The amount of this fee depends on the total cost paid to organise the event, in terms of direct and indirect funding.
Authorisation for training Conferences and Meetings
For training events, such as scientific conferences and meetings, the authorisation has to be applied via the information system ACC (Autorizzazione Convegni e Congressi, conferences and meetings authorisation). ACC is a dedicated platform for the management and authorisation of training events, ensuring the compliance of the regulations in force.
The request can be submitted by the ACC contact point of the company, an in-house figure to be appointed by the Company Users Administrator.
In the case of a single-sponsor event, the ACC contact point has access to the function for the upload of the “procedure” and then completes the “request” of authorisation.
If, instead, the event is sponsored by more companies, the management of the “procedure” is of an organising secretary, that uploads the event general information in the ACC platform and allows the company to complete the data missing in the section “richiesta” (application).
The role of the organising secretary
The organising secretary plays an essential role in the organisation of conferences, meetings and events. Not only they manage all logistic and operative aspects of the event, but also take care of coordinating the sponsors, regarding the form as well as the amount of the sponsorship.
The secretary also organises the single file to be enclosed in the authorisation application, including detailed information on the event (event programme and rationale).
The involvement of the organising secretary allows pharmaceutical companies to face the complexity of the regulations more easily, since they take care of all bureaucratic and administrative issues.
The benefit of entrusting a specialised consultant
The authorisation process for the organisation of pharmaceutical conferences and meetings is complex and burdened by bureaucratic compliance and deadlines to be met.
However, it is essential that companies respect the regulations to avoid fines and any problem with the competent authorities. In this context, availing oneself of a consultant specialised in medicinal product authorisations can make the difference, simplifying the whole process and ensuring the legal compliance.
A professional consultant offers several benefits:
- Time Maximisation: An expert consultant will be able to guide the company in filling in and submit the application promptly, preventing any delay that might compromise the event authorisation.
- Legal Compliance: The regulations for pharmaceutical conferences and meetings are detailed and under continuous progress. Experts are always updated on any regulatory change and know how to apply them correctly, ensuring the company compliance with all provisions in force.
- Full management: From the preparation of the required documentation up to the management of the online procedures, an expert consultant can take care of all steps, allowing the company to concentrate on the more strategic aspects of the event.
- Reduced Risk of Errors: The bureaucracy linked to the organisation of pharmaceutical events is complex and presents a margin of error along with many deadlines to be monitored. Entrusting professionals with this service minimises the risk of problems that could compromise the event authorisation, or even worse, the company’s image.
Conclusions
The organisation of pharmaceutical conferences and meetings is an essential activity for the sector’s companies wishing to promote scientific update and continuous training of health professionals.
However, it is essential that this activity occurs in compliance with the AIFA regulations, with special reference to authorisation procedures and sponsorship management.
To avoid bureaucratic issues and maximise time, pharmaceutical companies are strongly recommended to turn to consultants with expertise in the field of authorisations.
Thanks to a specialised advising, it is possible to be sure of an appropriate event organisation, complying with all regulations and ensuring full transparency and integrity.
Don’t let bureaucracy hinder your events’ success! Contact now our team of experts for professional advice and maximise your experience in the organisation of pharmaceutical conferences and meetings.