Learning area: Regulatory Affairs
Regulatory Product Information & Labelling Specialist Program
Focus on Product Information, labelling, mock-ups and the regulatory processes used to maintain and implement product-information changes.
BEST FORJunior / Specialist
Is this program for you?
Choose this program if you:
What will you focus on?
The curriculum concentrates on:
How the program works
A fixed focused curriculum included in the Regulatory Affairs learning area subscription.
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01.
Enroll in the program
Start the program on the AIDIFY platform with a learning area subscription.
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02.
Learn at your own pace
Complete the 10 program courses one by one and collect a certificate for each of them.
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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.
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Management of Company Core Safety Information
PharmacovigilanceRegulatory AffairsJulita Wójcik, Anna Kończak
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Managing Product Information updates depending on the type of procedure
Regulatory AffairsKatarzyna Kopacz-Zakrzewska -
Medicines under additional monitoring, the black triangle
PharmacovigilanceRegulatory AffairsKatarzyna Kopacz-Zakrzewska -
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Requirements for Product Information of medicinal products
Regulatory AffairsKatarzyna Kopacz-Zakrzewska
What you get in every course
Each course combines focused content, supporting resources and a clear completion path.
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 industryAbout
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
Julita Wójcik
Regulatory Affairs ManagerAbout
Pharmacovigilance and Regulatory Affairs Expert now mainly responsible for regulatory issues, including audit of the dossier, preparation and submission of documentation to the competent authorities. Involved in the work of the Pharmacovigilance Department including monitoring of safety information, case processing and preparation of periodic safety update reports. Biologist by training and graduate of studies in Pharmacoeconomics, HTA, Marketing and Pharmaceutical Law on Business School of Warsaw University of Technology. Lecturer has the title of Certified Regulatory Affairs Manager (CeRAM) at the Master level.
Over 15 years of experience in Pharmacovigilance and Regulatory Affairs area. Engaged in many processes of Marketing Authorisation applications, submission of postmarketing variations and renewals. Involved in preparation and verification of packaging information and verification of promotional materials. Experienced in collecting, translating and processing of Individual Case Safety Reports (ICSRs) and follow-up reports, preparation, implementation and update of Standard Operation Procedures (SOPs) concerning Pharmacovigilance.
Personally a mother of twins with good organization and management skills. Interested in Interior design, confectionery, local social and charity activities.
Skills:
- enthusiasm
- proficient at multi-tasking with good attention to detail
- strongly involved in ongoing projects and focused on the goal
- good interpersonal skills
Anna Kończak
Medical Projects ManagerAbout
Medical Projects Manager - skilled in leading, motivating, and coordinating teams and projects. Pharmacist. Mother of a 7-year-old girl.
With over 10 years of experience in the pharmacovigilance sector and expertise in medical information. More than three years of experience as a backup EU QPPV at Poland’s largest pharmaceutical company, Zakłady Farmaceutyczne “POLPHARMA” S.A. Contributed to the development and maintenance of a new set of SOPs and PSMF.
Pioneered a new model of pharmacovigilance activities, overseeing the procurement of pharmacovigilance services. Led the project to establish a new global pharmacovigilance structure for the Polpharma Group.
Nearly four years of experience in people management as the coordinator of periodic reporting and risk minimization teams. Managed 4-5 direct reports.
Responsibilities included:
- Aggregate reports
- Risk management (plans, routine and additional risk minimization activities)
- Pharmacovigilance training for company staff (8,000 employees)
- Safety data exchange agreements
- Pharmacovigilance service agreement
- Extended EudraVigilance Medicinal Product Dictionary reporting
- Post-authorization safety studies
- Safety reporting in clinical trials
Skills:
- Lean management
- Negotiation
- Intellectual curiosity
- Enthusiasm
- Persuasion skills
- Organizational skills
- Proficiency in multitasking with keen attention to detail
After-hours interests:
- Literature
- Rock music
- 1960s fashion and design
- Art history
- Camino de Santiago and the Trans-Siberian Railway
See where these skills are in demand
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READY TO GET STARTED?
Build focused skills for your pharma career
Get 10 courses and a job-ready certificate in one focused program, included in the Regulatory Affairs learning area subscription.