Description
This intensive course discusses current compliance issues and how the compliance organization impacts all areas of operations in the pharmaceutical industry. The presented material also applies to the biopharmaceutical, medical device and cosmetic industries, and shall be of interest yet for distributors.
The course is broken down into five modules (mini workshops), one module per week:
MODULE 1: we discover the general compliance principles and procedures, and look at what compliance actually influences and what it can do for your business in ethics & anti-corruption, data protection, training and education, social media among others.
MODULE 2: we discuss how to build an effective culture of compliance with competition law and help your business to avoid the many adverse potential consequences of competition law infringement.
MODULE 3: we take a detailed look at compliance with current public procurement legislation.
MODULE 4: we discuss how to ensure compliance with tax laws and regulations.
MODULE 5: we run through compliance with IP laws.
All in all, the course will put your employees on the right track to building better compliance for the business, and be more confident in routine business solutions.
The course is presented in an open, interactive manner, encouraging discussion throughout all modules, on a weekly basis (one module per week).
PROGRAM
MODULE 1. General Compliance
Speaker: Oleksii Bezhevets, partner
90 min workshop + 30 min Q&A
- Anti-Corruption: policies, SOPs, grants, ungrounded benefits, interaction with HSPs, special proposals on promotion, education, charity, sponsorship
- Auditing and Monitoring: due diligence of counterparts and other questions for compliance officer
- Education and Training: for colleagues and for HCPs
- Ethics: the Ethical Code and ethical issues
- Personal data protection: GDPR and Ukrainian legislation
- Internal Investigations
- Counterfeiting drugs: sensible issues
- Social Media: the company and the employees
MODULE 2. Compliance in Competition
Speaker: Andrii Gorbatenko, partner
60 min workshop + 30 min Q&A
- Distribution
- Agreements with pharmacies
- Unfair competition in promotional activities
MODULE 3. State Procurement in Pharma
Speaker: Olexander Bondar, counsel
60 min workshop + 30 min Q&A
- Current legal requirements and compliance issues
- Prospect legislation and challenges in 2021
MODULE 4. Tax
Speaker: Vitalii Savchuk, counsel
60 min workshop + 30 min Q&A
- Tax risks LLCs and permanent establishments face
- Tax risks representative offices face
- New requirements for the non-residents and their permanent establishments introduced in 2021
MODULE 5. Intellectual Property Highlights for Pharmaceuticals
Speaker: Vitalii Savchuk, counsel
60 min workshop + 30 min Q&A
- Bolar exception and other novellas that shall influence the market and public procurement
- Effective means to protect IP portfolio
- Introduction to combating counterfeit goods
This course includes
- 8 hours of online/virtual training
- Certificate of completion issued by Legal Alliance
Who this course is for
The training will be beneficial to middle and senior managers, administrators and executives working in the following areas:
- Business Development & Marketing
- Legal / Regulatory Affairs
- Finances and Accounting
- Ethics & Compliance
- State Procurements
- Quality Assurance & Control
Upskill your team
The course is organized for teams of managers (there is no limit in a number of participants), as on-demand interactive online training for the company employees, and could be organized in comfortable hours.
The language of the course is Ukrainian/Russian/English, as requested by the company.
The price of a 5-module course is 2400 Euro. ACC members get a 10% discount.
To book a course, please contact the course director Oleksii Bezhevets at bezhevets@l-a.com.ua or by phone +380 44 425 40 50.
