Szkoła Prawa Farmaceutycznego Warszawa | Podyplomowe studia farmaceutyczne

Description

School of Pharmaceutical Law – Pharmaceutical law in practice

Pharmaceutical Law School is a unique opportunity to benefit from the practical knowledge of both public administration experts—who assess the activities of pharmaceutical market participants—and advisors who implement life science projects. Our lecturers are experienced practitioners who carry out business projects for entities operating in the pharmaceutical market as well as heads of expert units within public administration.

By choosing the educational offering of the Pharmaceutical Law School, you will gain practical and applicable knowledge about the most important processes carried out by entities within the pharmaceutical sector. You will learn, among other things, how to:

Obtain authorizations for the manufacture or import of medicinal products
Open a pharmaceutical wholesale warehouse
Open a pharmacy or transfer a license to another entity
Legally import and trade non-fibrous cannabis
Place medicinal products on the market
Register clinical trials
Navigate the reimbursement process
Advertise pharmacies and medicinal products legally
Prepare for inspections by the pharmaceutical inspectorate
Defend your rights during product withdrawal procedures
Design an appropriate distribution model for medicinal products.

Opłata

Fee for the 1st Edition of the Pharmaceutical Law School

One-time payment – PLN 7,000
Payment in two instalments – 2 × PLN 3,600, i.e. PLN 7,200

It is also possible to purchase individual modules:

Module 1 – Wholesale Trade and Manufacture of Medicinal Products (48 hours of classes) – PLN 4,100
Module 2 – Retail Trade in Medicinal Products (34 hours of classes) – PLN 2,900
Module 3 – Registration and Reimbursement of Medicinal Products (42 hours of classes) – PLN 3,600

Or combined module packages (discounted due to overlapping content):

Module I + II – PLN 5,100
Module II + III – PLN 5,600
Module I + III – PLN 6,400

Information for participants whose fee is covered by their employer:

Invoices will be issued after payment is made.

Bank account number for payments:
41 1240 6263 1111 0010 6150 1662
Payment reference: Pharmaceutical Law School, Participant’s First and Last Name

School program

The School of Pharmaceutical Law is organized by the Foundation for the Faculty of Management (Education Center of the Foundation of the Faculty of Management) together with the Faculty of Management of the University of Warsaw.

Meetings are held hybridly at the Faculty of Management of the University of Warsaw.

Classes will be held on weekends (Saturday and Sunday), every two weeks at the following times:

Saturdays: 9:00 AM - 4:00 PM
Sundays: 9:00 AM - 2:00 PM

Obtaining a license to conduct wholesale trade in medicinal products	8
Introduction and distribution of medicinal products	4
Mediation in the trade of medicinal products	2
Uzyskanie zezwolenia na prowadzenie obrotu hurtowego produktami leczniczymi	8
Obtaining a license to conduct wholesale trade in medicinal products	6
ZSMOPL – Integrated System for Monitoring the Trade in Medicinal Products	2
Verification of the authenticity of medicinal products from the perspective of the manufacturer, importer, wholesaler, and pharmacies	6
Inspection supervision	8
Legal conditions for the manufacture and trade of non-fibrous cannabis	4
Obtaining a license to operate a community pharmacy	8

Quality of medicinal products	6
Legal conditions for advertising pharmacies, medicinal products, and dietary supplements	4
Placing medicinal products on the market	6
Supervision of the safety of medicinal product use	8
Reimbursement of medicinal products	8
Clinical trials	6
Naming of medicinal products	2
The role of the Agency for Health Technology Assessment and Tariff System in the healthcare system	2
	98

Announcements

21 maja 2025

Recruitment – Edition II

We invite you to register for the 2nd edition – Recruitment starts on June 5.

If you have any questions, please contact us at: spf@wz.uw.edu.pl.

20 maja 2025

Meeting dates

The meeting dates for the Pharmaceutical Law School are now available:

See you there!

Recruitment

Fill out the form and send it!

Recruitment for the 2nd edition will begin in June 2025.
We invite you to submit your application to receive up-to-date information about the recruitment process -> here

Duration: one academic semester

Recruitment Description:

Recruitment rules, including required documents:

Recruitment period: June 2025

To apply, candidates must register by filling out the application form available on the website and providing the required information. Recruitment is conducted on a first-come, first-served basis.
Fill out the form and send it!

Qualified candidates are required to submit a complete set of documents:

Application for admission to the program
Curriculum Vitae (CV)
Declaration of commitment to cover the tuition fees

Candidates will be admitted on a first-come, first-served basis.

Paper documents must be submitted either in person to Room C204 or sent by registered mail to the following address:

Faculty of Management
University of Warsaw
ul. Szturmowa 1/3
02-678 Warsaw, Poland

Please include the note: “School of Pharmaceutical Law” on the envelope.

Class Schedule

Pharmaceutical Law School- edition I [2024/2025]

Full Program

Fees

Lecturers

Andrzej Czesławski

Director of the Department for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

A graduate of the Faculty of Pharmacy at the Medical University of Warsaw. From 2005 to 2015, he worked in the field of marketing authorization of medicinal products within both European and national procedures. In his daily work, he led a team responsible for coordinating and conducting marketing authorization processes in mutual recognition and decentralized procedures.

Over the years, he has gained extensive knowledge in the field of electronic submission formats for regulatory documentation. He currently heads the team responsible for overseeing the safety of pharmacotherapy. He is also a long-standing European expert of the European Medicines Agency.

Natalia Falęcka - Tyszka

Legal Counsel

She specializes in providing legal advice to entities operating in regulated industries—particularly in the pharmaceutical, medical devices, food, and healthcare sectors. She has extensive practical experience gained at the Chief Pharmaceutical Inspectorate, where she served as Head of the Adjudication Division for Retail Trade.

She advises and represents clients before public administration authorities as well as administrative courts. She has significant experience in developing market strategies, including the assessment of distribution and marketing policies. Natalia also represents industry organizations operating in the pharmacy sector.

Her experience in both the public and private sectors—including collaboration with leading law firms—enables her to offer comprehensive legal support to Life Sciences & Healthcare companies, while taking into account the regulatory specifics of each industry.

Joanna Grynfelder

Legal Counsel

A graduate of law studies and the Business Law program at the Faculty of Law and Administration of Cardinal Stefan Wyszyński University in Warsaw, as well as the legal counsel training program at the District Chamber of Legal Advisers in Warsaw. She is currently enrolled in postgraduate studies in Medical Law at the Institute of Legal Sciences of the Polish Academy of Sciences. She is a registered legal counsel with the District Chamber of Legal Advisers in Warsaw.

Professionally, she has been affiliated with the National Medicines Institute in Warsaw since 2017.

dr Michał Kaczmarski

Doctor of Law, Attorney-at-Law

A graduate of the Faculty of Law and Administration at the University of Warsaw, and Assistant Professor at the Institute of Accounting, College of Management and Finance at the Warsaw School of Economics (SGH). From 2017 to 2020, he served as President of the Foundation for the National Organization for the Verification of the Authenticity of Medicines (KOWAL).

He has been a long-time associate of Big Four advisory firms (Deloitte, EY, KPMG) and a former compliance manager at an international pharmaceutical company, where he was responsible for the compliance program in Poland and the Baltic States.

Katarzyna Kęsik Olędzka

Former Deputy Director of the Supervision Department at the Chief Pharmaceutical Inspectorate, currently providing consultancy services to pharmaceutical market participants

A Master of Pharmacy, consultant, trainer, and auditor in the pharmaceutical industry. She is a graduate of the Faculty of Pharmacy at the Medical University of Warsaw and completed postgraduate studies in chemical metrology at the Faculty of Chemistry, University of Warsaw. She is a certified auditor for ISO 9001, ISO 17025, and ISO 13485 standards.

She began her professional career in the Quality Control Department at one of the largest pharmaceutical companies in Poland. She later spent many years at the Chief Pharmaceutical Inspectorate, initially serving as a manufacturing inspector, then as Head of the Department for Monitoring the Trade in Medicinal Products and the Department for Falsified Medicinal Products. Ultimately, she held the position of Deputy Director of the Supervision Department.

In this role, she shaped the development and improvement of wholesale trade inspections, contributed to the drafting of legislative proposals and executive regulations in the fields of pharmacy and drug prevention, and represented Polish pharmaceutical supervision internationally. For over a year, she collaborated with a law firm providing advisory services to the life sciences sector.

Joanna Kmiecik-Grudzień

Director of the Department for Post-Authorization Changes and Re-registration of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

A pharmacist and graduate in economics with a specialization in international trade from the Higher School of Commerce and Law. She has 5 years of experience working in a pharmacy. From 1999 to 2002, she worked at the Department of Drug Policy and Pharmacy at the Ministry of Health. Since 2002, she has been affiliated with the Office for Registration, where she currently oversees and coordinates the work of the department responsible for implementing post-authorization changes and re-registration of medicinal products.

She actively participates in the development and review of legal acts related to the healthcare sector and is a member of several expert teams appointed by the Minister of Health in connection with the pharmaceutical sector.

dr hab. Anna Kowalczuk

Deputy President of the Agency for Health Technology Assessment and Tariff System

A manager with nearly 20 years of experience in the pharmaceutical sector, she possesses extensive knowledge of the healthcare system as well as hands-on experience in cross-sector collaboration and the implementation of development strategies.

An expert in healthcare, she has served on numerous advisory teams and scientific councils, including:

The Committee for Medicinal Products at the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB)
The Team for Active Pharmaceutical Ingredients at the Ministry of Development, Labour and Technology
The Scientific Council of the Institute of Physiology and Pathology of Hearing
The Scientific Council of the National Institute of Geriatrics, Rheumatology and Rehabilitation
The European Pharmacopoeia Commission: Herbal Drugs and Herbal Drug Products
Advisory groups of the European Directorate for the Quality of Medicines (EDQM) in Strasbourg: EDQM Advisory Group CAP and EDQM Communication Working Group

From 2017 to 2022, she served as Director of the National Medicines Institute (NIL), and from 2015 to 2017, she was Deputy Director for Quality Control Research at Poland’s OMCL (Official Medicines Control Laboratory).

Anna Kowalczuk is a pharmacist by education. She graduated in pharmacy from the Medical University of Warsaw and completed postgraduate management studies at the University of Warsaw (UW), as well as an Executive MBA (EMBA) at UW.

In 2024, she earned her postdoctoral degree (habilitation) in the field of medical sciences and health sciences.

She is the author of numerous scientific publications in national and international journals, the creator of postgraduate study programs, a frequent expert speaker at scientific conferences, panelist, and lecturer.

Michał Pietrusiński

Legal Counsel

A graduate of the Faculty of Law and Administration at the University of Warsaw. He is registered with the District Chamber of Legal Advisers in Warsaw. Michał Pietrusiński has over a decade of experience providing legal services in the areas of civil law, commercial law, and labor law.

For many years, he collaborated with the Legal Department of the Chief Pharmaceutical Inspectorate and headed the Legal Office at the National Medicines Institute. He lectures on pharmaceutical law at the University of Warsaw and at the Kozminski University in Warsaw. Michał Pietrusiński is also the President of the Board of the Lex Pharma Foundation.

Mateusz Oczkowski

Deputy Director of the Department of Drug Policy and Pharmacy at the Ministry of Health

Master of Pharmacy with several years of experience in the areas of reimbursement and pharmacoeconomics. Graduate of the Medical University of Warsaw and Lazarski University.

Chairman of the Economic Committee, an advisory body to the Minister of Health responsible for setting the prices of reimbursed products.

Magdalena Rychter

Deputy Director of the Department of Pharmaceutical Supervision at the Chief Pharmaceutical Inspectorate (GIF)

A pharmacist and graduate of the Medical University of Lublin. Shortly after graduation, she worked for several years in a community pharmacy. Since 2019, she has been affiliated with the Chief Pharmaceutical Inspectorate. She initially served as an inspector for wholesale trade, later became Head of the Department for Monitoring the Trade in Medicinal Products, and since 2022, has held the position of Deputy Director of the Department of Pharmaceutical Supervision at GIF.

As part of her responsibilities, she actively participates in managing medicine availability issues, analyzing irregularities in the distribution chain, and supervising the trade in controlled substances.

Paulina Sosin-Ziarkiewicz

Deputy Director of the Department of Drug Policy and Pharmacy at the Ministry of Health

She is a lawyer specializing in pharmaceutical law and administrative procedures. She has extensive experience in handling matters related to the operations of manufacturers and importers of medicinal products, pharmaceutical wholesalers, pharmacies, advertising of medicinal products, as well as inspections and supervision of entities operating in the pharmaceutical market. Her experience comes from working in public administration within the healthcare sector and in an organization representing international pharmaceutical companies.

For many years, she served as Director of the Legal Department at the Chief Pharmaceutical Inspectorate. As a legislator, she has long-standing experience in leading legislative processes, particularly in the amendment of the Pharmaceutical Law Act, the Act on Counteracting Drug Addiction, and numerous implementing regulations.

dr n. farm. Paweł Szoka

Director of the Department of Clinical Trials of Medicinal Products

He has over 19 years of experience in the broadly understood field of registration of medicinal and veterinary medicinal products. His expertise includes the evaluation of registration documentation as well as processes related to marketing authorization, post-authorization changes, and re-registration. Since 2018, he has been involved in clinical trials of medicinal products, focusing on coordinating registration processes and assessing investigational medicinal product documentation.

Romuald Żywiecki

Patent Attorney, Lawyer

He has been involved in industrial property law since 2007. He specializes in the protection and management of trademark portfolios in the pharmaceutical sector. For nearly 8 years, he was responsible for the global management of a large trademark portfolio for one of Poland’s leading companies. From 2020 to 2022, he chaired the IP Working Group at the Polish Union of Pharmaceutical Industry Employers.

School of Pharmaceutical Law

Student office

School Coordinator