Hello! I am Katarzyna, currently serving as a Junior Pharmacovigilance Manager at Teva Pharmaceuticals, and I am eager to welcome you to the AIDIFY platform.

My journey in the field of Pharmacovigilance has been both diverse and enlightening. After kick-starting my career as a Senior Pharmacovigilance and Regulatory Affairs Specialist, I ascended to more focused roles such as Pharmacovigilance and Eudravigilance Expert, and later as a Manager at Rapofarm. These varied experiences have equipped me with a wealth of knowledge and practical insights in the arena of drug safety.

I hold a Master's degree in Pharmacy from the distinguished Medical University of Warsaw, an academic foundation that has significantly influenced my professional pathway. This solid theoretical groundwork, combined with my industry experience, enables me to provide a comprehensive and applied learning experience.

On this e-learning platform, I am excited to share my insights, tips, and experiences. I am here to help you navigate the intriguing world of Pharmacovigilance and ensure your journey is as enlightening as it is rewarding.

So, come join me, and let's embark on this enriching learning expedition together. The journey to mastering Pharmacovigilance begins now.

My name is Karolina Smyl and I am a Pharmacist graduated from the Warsaw Medical University in Poland, University of Alcala in Spain as well as postgraduate studies in medical business management. I have 10 years of experience working in the area of Pharmacovigilance. Currently I work as a PV Expert in Medical Department at pharmaceutical company Polpharma, which is a leader of the Polish pharmaceutical market and one of the leading drug manufacturers in the region of Central and Eastern Europe. I am also a member of Polish Society of Pharmacovigilance.

My main responsibilities include preparation of specific pharmacovigilance documents so-called aggregate reports i.e. Periodic Safety Update Reports (PSURs), Addendum to Clinical Overview (ACO), , Development Safety Update Reports (DSURs) from clinical trials, Benefit/Risk Analysis. Risk Management Plans (RMPs) and Additional risk minimization measure (aRMM) are my favorites. I am also responsible for vendors of pharmacovigilance service acquisition.

My daily activities also include updating of Extended EudraVigilance medicinal product dictionary (XEVMPD). Moreover, I supervise the processes related to Safety Data Exchange Agreements.

Since 4 years I have been a PV trainer responsible for initial and annual PV trainings for all employees of the company.

Privately, I am a mother of two wonderful children, with whom I enjoy exploring the world and spending time actively, focusing on a healthy lifestyle.

I encourage you to contact me after the course and for this purpose I leave a link to my LinkedIn.

Hello! I'm Monika, a seasoned professional in the Pharma industry, and I'm thrilled to welcome you to my SME page on the AIDIFY platform.

With over 15 years in the field, serving as the Head of Country Pharmacovigilance in a major global pharma company and as the Vice President of the Polish Society of Pharmacovigilance, I've gathered a wealth of knowledge and experience that I'm eager to share with you.

In my roles, I'm directly involved in setting industry standards and keeping my finger on the pulse of the latest trends, thanks to leading the Pharmacovigilance working group in Infarma. I've honed the ability to break down complex concepts into easily understandable lessons, an asset that will serve you well on this educational journey.

As a co-author of the 'Pharmacovigilance Guide', I've laid out comprehensive expertise in print. Now, through this e-learning platform, I look forward to directly engaging with you, sharing my insights, and helping you reach new heights in your career.

Join me, let's broaden your horizons together in the Pharma industry. Your journey starts now.

Hello there! I'm Marek, a seasoned lawyer with a deep-rooted interest in drug safety. I'm delighted to welcome you to our top-notch AIDIFY platform where we aim to enrich your understanding of the Pharma industry.

I have devoted years of my career to understanding and navigating the complex world of pharmaceutical regulations, with a strong emphasis on pharmacovigilance. This unique intersection of law and drug safety has offered me a distinct viewpoint, one that I am eager to share with you.

As a proud member of the Polish Society of Pharmacovigilance, I'm continuously updating my knowledge and understanding of the industry's intricacies, keeping myself aligned with the latest trends, regulations, and safety practices.

Having served in various Pharma companies over the years, I've acquired not just theoretical knowledge, but also a wealth of practical insights. I firmly believe in blending theory with practice, which allows me to offer you a balanced and comprehensive learning experience.

Join me on this educational journey, where I aim to equip you with a well-rounded understanding of pharmacovigilance and its legal aspects. Let's shape your future in the Pharma industry together. Your journey with me begins now.

Aleksandra is a pharmacist with many years of experience in pharmacovigilance. After graduating, she joined Pfizer as a Junior Safety Data Management Specialist working in the Hub supporting all European countries, Middle East and Africa where she gained experience in case processing activities, triage and acceptance of reports coming from Eudravigilance database and submission to Ethics Committees and Investigators. Currently she manages a team of safety specialists.

Along with her weak spot for the literature cases she is also keenly interested in signal detection.

Passionate about further broadening of her knowledge she regularly participates in numerous trainings, e.g. ‘Signal and Risk Management in Pharmacovigilance MasterClass’ in November 2020, organized by Global Leading Conference, ‘Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors’ in May 2022, postgraduate studies “Management and Monitoring of Clinical Trials” in 2019 at Kozminski University.

Knowing that her work has an impact on health and safety of patients is the greatest motivation and gives her a lot of satisfaction.

When she is not working you can usually meet her cycling or playing squash. She is also interested in learning different languages as they help her to explore new cultures around the world.

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

Hello, my name is Andrzej Czesławski. I am a graduate of the Faculty of Pharmacy at the Medical University of Warsaw. Since 2005 I work for the polish health authority - the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. I have more ten years' experience in regulatory affairs especially in European procedures. From 2005 to 2015, I worked in the area related with coordination of the process of granting marketing authorization of the medicinal product in the Mutual Recognition and Decentralised Procedures starting as a junior specialist and finishing as a head of the unit and deputy director of the department. At the end of 2015 I decided to change something in my professional life and joined pharmacovigilance teem to look for some more challenges as a head of the department. Additionally I am an European expert of the European Medicinal Agency. Lastly what I am mostly proud of is that I am a member of the CMDh - the Co-ordination Group for Mutual recognition and decentralise procedure. In 2011 I was officially nominated as an alternate member and since July 2020 I am a member of the CMDh. Being a part of the CMDh allows me to use my experience in the field of regulatory affairs and pharmacovigilance.