Education

Educational program - INTENTION: "HOLDER-PROVIDER"

• To clarify legislative changes concerning the pharmaceutical companies’ business, regulating their relationships with healthcare providers, which have been passed in the last 2 years.
• Law on Advertising, EU Directive 2001/83 / EC, Law on medicines, Law on health care providers, Income Tax Law, or outside-the-law regulations such as the Code of Ethics AIFP to name just few ( albeit critical) regulatory standards, at the correct interpretation of which the training/educational program is aiming.

Target: 

• By completing this training the participants will get comprehensive knowledge in the field of environment of pharmaceutical companies, regarding the regulation of relations with healthcare professionals.
• To increase and enhance the legal awareness (relevant provisions of the Law on medicines, Advertising law, Income Tax Law, etc.), as well as the interpretation of the latest legislative changes. 
• Based on field experience, the participants will get acquainted with the most frequently occurring errors, and most importantly, we will present you with proposals for practical solutions based on the assessment of the particular situation.

General content based on individual agreement:

The relationships between pharmaceutical companies and healthcare providers are charted on two levels:

1. Assessment of legal limits of cooperation (what is legally allowed, possible, and in what framework)
2. Subsequent identification of the rights and obligations arising from such relationship.

Examples of training topics / lectures:

• Tax and reporting obligations in connection with the participation of health-care workers in professional training activities, depending on the nature of the event
• oes Advertising law allow the marketing activities of pharmaceutical companies focused on health-care professionals?
• Withholding tax in the pharmaceutical sector - positive and negative.
• Continuing education of healthcare professionals - professional conference abroad.
• What do they have in common: Sunshine Act (USA) AIFP Code of Ethics and the Law on the medicine?
• Where are the limits of legitimate relationship of pharmaceutical companies and healthcare professionals as set by Advertising law, Law on Medicines and the Income Tax Law?
• Is the pharmaceutical company allowed to provide samples of medicinal products?
• What are the different rights and obligations of each holder (namely the difference between the pharmaceutical company and the holder of the human medicine registration)?
• Practical advice: deadlines, forms, reporting methods, calculations, types of suitable contractual relations (focus on copyright law contracts and consulting contracts), taxes, levies, fees to Literary Fund etc.
• The issue of "third parties" for the purposes of taxation and reporting.
• Reporting of provided pecuniary income or benefits-in-kind to the National Centre in the context of the
• Personal Data Protection Law

... or based on the specific requirements the content would be individually processed..

Forms and methods:

Presentation, facilitated discussion.

Range:

Lecture at public events: according to individual agreement depending on the selected topic and scope.

The guarrantee of the training program is Lecturer: MUDr. Rudolf Straka Bc.

Specialist in medical and pharmaceutical environment, university teacher. Focus on legislative and economic aspects of the pharmaceutical and healthcare sector. Identification and addressing of specific approaches in this area. Long-term personal experience in clinical medicine and the pharmaceutical industry.