Marta Jaśkiewicz-Łajszczak

Associate

Marta Jaśkiewicz-Łajszczak
phone:
+48 22 326 9600
mobile:
+48 882 680 935
office:
Warsaw

Marta specializes assisting entities in the pharmaceutical and health care business. Advises in providing legal services on trading medicinal products and medical devices, including pharmaceutical companies, pharmacies and pharmaceutical wholesalers.

Furthermore, Marta possesses rich experience in the establishing of healthcare companies and providing complex services for such entities, including telemedicine, preparation of standard operating procedures concerning pharmaceutical and healthcare business and compliance audits.

Before she joined KZP, Marta built up her professional experience in Polish and international law firms, including the Life Sciences practice of Domański Zakrzewski Palinka law firm.

Languages: Polish, English.

Membership: The Warsaw Bar of Legal Advisors (2nd year trainee).

Education: Wroclaw University, Master of Law (2012); Jagiellonian University, Post-graduate studies „Mediation and other alternative dispute resolution methods” (2014).

    Advice on regulatory matters
  • Participating in the preparation of a regulatory impact assessment report on the possible development of telemedicine in Poland.
  • Developing a regulatory impact assessment report on the situation of disabled people and the required legislative changes to remove existing barriers.
  • Preparing draft amendments to the Regulation of the Minister of Health on the Good Distribution Practice requirements.
  • Developing an action plan in connection with the amendment to the regulations on Emergency Medical Services in Poland and public financing of healthcare services, at the request of clients from the healthcare sector.
  • Preparing cyclical regulatory impact assessment reports for telemedicine companies.
  • Healthcare entities
  • Support in preparing a business model and preparing documents for a telemedicine company.
  • Reviewing and drafting agreements for healthcare entities.
  • Assistance in the process of registration of healthcare entities.
  • Day-to-day advice to pharmaceutical companies and manufacturers of medical devices
  • Comprehensive day-to-day advice to pharmaceutical companies (big pharma) including among others: review and verification of agreements, marketing activities, relationships with healthcare professionals.
  • Reviewing clinical study agreements between the client (a pharmaceutical company) and researchers and research units.
  • Assistance to a manufacturer of medical devices in developing the PSP (patient support program) in connection with legislative changes and adapting the PSP to the amended code of professional conduct.
  • Compliance
  • Compliance advice to pharmaceutical companies, including drafting and verifying compliance procedures.
  • Performing compliance audits in pharmaceutical and medical devices companies to verify the effectiveness of the compliance systems implemented or to prepare for a merger/acquisition (due diligence).