Learning area: Regulatory Affairs

Local Regulatory Affairs Specialist Program

Build knowledge of the regulatory activities used to maintain products and support compliance at local affiliate and market level.

BEST FORJunior / Specialist
Get access to this program

10 courses

Fixed curriculumThe 10 courses are selected around knowledge relevant to the program focus and combine regulatory foundations with practical, process-focused context.

Regulatory Affairs

Learning area subscriptionAll courses in this program are included in the Regulatory Affairs learning area subscription.

11 certificates

Course and job-ready certificatesReceive a certificate after every completed course and an additional certificate after completing the full program.

2 SME

Experts behind this programThe courses were developed with subject matter experts experienced in the relevant areas of pharma and life sciences.

Self-paced

Learn at your own paceThe program courses are available while the learning area subscription is active.

12h 27m

Estimated learning timeCalculated from the current duration of the 10 courses.

Is this program for you?

Choose this program if you:
  • Want to work in a local Regulatory Affairs team
  • Are interested in maintaining authorised products on a specific market
  • Want to combine local submissions, Product Information, fees, referrals and regulatory procedures
  • Prefer broad market ownership over a narrow submission- or labelling-only role

What will you focus on?

The curriculum concentrates on:
  • Post-authorisation lifecycle
  • Local Product Information and mock-ups
  • Electronic submissions and Module 1
  • EU authorisation procedures
  • Polish/local regulatory requirements
  • Fees and referral procedures

How the program works

A fixed focused curriculum included in the Regulatory Affairs learning area subscription.
  • 01.
    Enroll in the program

    Start the program on the AIDIFY platform with a learning area subscription.

  • 02.
    Learn at your own pace

    Complete the 10 program courses one by one and collect a certificate for each of them.

  • 03.
    Complete the program

    Finish all 10 courses to earn the job-ready certificate.

FIXED CURRICULUM

10 courses in the program

The fixed focused curriculum of this program. Open any course to explore its content and learning outcomes.

What you get in every course

Each course combines focused content, supporting resources and a clear completion path.

Video microlearning

Focused video lessons designed for flexible, self-paced learning and easy revision.

Course resources

A course presentation and references supporting the material covered in the lessons.

Practical learning

Practical activities and additional materials where available for the selected course.

Assessment and certificate

A knowledge test and an individual Certificate of Completion after successful completion.

PROGRAM EXPERTS

Meet the experts behind this program

Meet the specialists teaching the courses included in this program.
Katarzyna Kopacz-Zakrzewska
Regulatory professional in pharma industry

About

Work experience:

  • Regulatory Associate Manager in the multinational pharmaceutical company with over 6 years of experience in the industry.
  • Managing early development oncology programs (registrational planning and strategy building, leading preparations for EMA scientific advice, ODD, EU PIP etc.).
  • Pre-registrational stage: management of clinical trial documentation (substantial, non-substantial amendments of IB/Clinical Protocol/IMPD); managing Response to Questions from Health Authorities; leading preparations for transitions and new applications under EU CTR).
  • Post-authorisation stage: performing and being responsible for wide array of procedures for medicinal products registered in the EU (via CP/MRP/DCP procedures) and nationally registered products in Poland, such as: MAAs, renewals, variations, referrals, notifications, gap analysis, withdrawals of medicinal products, leading Response to Questions from Health Authorities, resolving validation enquires; global project management of variations and MAH transfer.
  • Providing regulatory recommendations on marketing and promotional materials.
  • Maintaining effective and professional communication with Health Authorities and other relevant stakeholders.
  • Speaker in multiple conferences for healthcare professionals and pharmacy students in both national and international level; delivering trainings and participant of multiple healthcare conferences, soft and hard skills trainings / workshops.

Education:

  • Pharmacy, MPharm at Jagiellonian University Medical College in Cracow, Poland (2017)
  • Interdisciplinary Studies in Pharmaceutical Management at Business School, Warsaw University of Technology, Poland (2019)

Achievements:

  • Laureate of leadership programme of American Chamber of Commerce “30 Under 30”, 7th edition, 2021- 2022.
  • Laureate of programme „Leaders of healthcare sector” of Leslaw A. Paga Fundation, Warsaw, Poland. The main aim of that educational project is to qualify and train the best and open for changes management staff in healthcare sector.
  • Soft skills trainer with growing mindset who is so enthusiastic in self-development, effective communication and public speaking improving skills.
  • Polish Pharmaceutical Students’ Association (PPSA) – association initiator and the first national president in 2016; EPSA Alumna since 2017.
  • Toastmasters- non-profit organization that teaches public speaking and leadership skills – these both encourage me to be AIDIFY SME

Certificates HARD:

  • Pharmacoeconomics, Business School, Warsaw University of Technology
  • Clinical Trials and drug development, Business School, Warsaw University of Technology
  • Selling and marketing of medicinal products, Business School, Warsaw University of Technology
  • GMP, Business School, Warsaw University of Technology
  • Regulatory Specialist – workshop
  • Medical Devices in light of new regulation
  • Variation documentation preparation – workshop
  • Variations and renewals
  • Product information for medicinal products, 2018

Certificates SOFT:

  • Thinking Environment Course, 2022
  • LEAN Practitioner, 2021
  • Project Management Fundamentals, 2021
  • Virtual Presentation Skills, 2021
  • Toastmaster “Competent Communicator”, 2020
  • Trainers Development Camp, 2016

Joanna Kupidura
Senior Regulatory & Pharmacovigilance Specialist

About

Professional Summary

I am Regulatory Affairs Expert with over 11 years of experience in medicinal products registration and maintaining procedures and with understanding the need for close cooperation with medical, pharmacovigilance, marketing and supply departments. I am looking for new opportunities to expand the knowledge in areas connected with lifecycle of the medicinal product and now I am getting to know the area of Pharmacovigilance with all its curiosities. I am deeply convinced that clear and simple communication is very valuable in learning processes so I prepare courses that are based on my experience and I try to show you all the regulatory affairs secrets that I discovered over the years.

I started my adventure with Regulatory Affairs Department in 2010 as Regulatory Affairs Specialist and each year expanded my experience in:

  • registration activities
  • coordination and implementation of european projects on local level
  • working with Document & Data Management Systems
  • monitoring Authorities requirements
  • quality check of national dossier
  • preparation and updating of local Standard Operating Procedures and Working Instructions.

I hope my courses will be interesting, useful, easy to remember and what is most important understandable to you. Good luck!

Education

Warsaw University of Technology
Department of Chemical and Process Engineering
Master’s Degree, Biotechnology in Industry

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