Meet AIDIFY's experts

With over 18 years of experience in IT, Łukasz specializes in various aspects of this field – from game programming and backend development, to leading teams and technological departments. His strengths lie in effective communication, conflict resolution, and a business-focused approach. He subscribes to the principles of minimalism and essentialism, striving for the simplest but most effective solutions. He also enjoys sharing his knowledge as a speaker and fights against toxic productivity, promoting a healthy approach to work.

Anna Buczyńska-Borowy is a highly respected figure in the field of data protection and privacy, renowned for her expertise and contributions to the industry. With a distinguished career spanning decades, Anna has established herself as a leading authority in this rapidly evolving domain.

Currently serving as the Managing Director of AB Advisory, Anna brings a wealth of knowledge and experience to her role. In addition to her leadership at AB Advisory, Anna holds the esteemed position of Vice President of the Board at the Józef Wybicki Foundation, where she plays a pivotal role in driving initiatives focused on social impact and community development.

Anna's dedication to advancing data protection practices is evident through her role as the Founder and Lead Lecturer at the Academy of Data Protection (Akademia ODO), where she imparts her insights to the next generation of data protection professionals. As a Certified Lead Auditor for ISO 27001 and a Certified Data Protection Officer (IOD/DPO), Anna is committed to upholding the highest standards of privacy and security in her work.

As a member of the Committee for Personal Data Protection at the National Chamber of Commerce, Anna actively shapes policy discussions and advocates for best practices in data protection. Her involvement in industry initiatives such as "Art & Privacy" and "Women In ODO" (WIn ODO) underscores her dedication to promoting diversity and inclusion in the field.

Anna's contributions extend beyond her professional endeavors, as she is also the author of various publications, including "Szacowanie ryzyka dla ochrony danych osobowych na gruncie RODO. Od teorii do praktyki," a seminal work in the field of data protection.

With her comprehensive expertise and unwavering commitment to excellence, Anna Buczyńska-Borowy is a trusted authority and sought-after speaker at conferences and events worldwide, where she shares her insights and best practices on topics related to data protection and privacy. Her impact on the industry is profound, and her dedication to advancing data protection standards continues to inspire professionals globally.

Monika Czerwiński is a seasoned clinical research executive with over 14 years of industry experience. She serves as Executive Director at HolsäClinical, part of the Gyncentrum Group, where she leads the strategic development and scaling of a nationwide network of clinical research sites.

She is the founder of Trial Leaders Academy, a platform dedicated to developing the next generation of clinical research leaders. She is also an active member of the GCPpl community, where she leads the Clinical Research Coordinators School, contributing to the advancement of professional standards across the industry.

Monika brings comprehensive expertise across the full clinical trial lifecycle, with a background spanning roles in study coordination, monitoring, and site management. She has successfully led initiatives across multiple therapeutic areas, including oncology, hematology, cardiology, gynecology, and dermatology.

She holds a degree in Biomedical Engineering from the University of Silesia and completed postgraduate studies in Project Management at the Warsaw School of Economics. Her core expertise lies in clinical trial feasibility and the effective execution of study start-up and site operations at scale.

Since 2020, she has played a pivotal role in shaping HolsäClinical’s growth and operational model, driving innovation in clinical research delivery in Poland. She combines deep operational insight with a forward-looking approach, with a particular focus on leveraging artificial intelligence in clinical trials.

A recognized speaker and thought leader, she actively contributes to industry dialogue, promoting higher standards of quality, efficiency, and innovation in clinical research.

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.

Master of Pharmacy, safety assessor and owner Ewelina Drelich Consulting, lecturer in Warsaw College of Helath and Engineering (safety assessment of cosmetics products; quality of cosmetic products), consultant of the cosmetics and pharmaceutical market, member of the Polish Association of Cosmetic and Detergent Industry. Author of publications in industry magazines, including „Świat Przemysłu Kosmetycznego”, „Chemia i Biznes”, „Kwartalnik Chemiczny”. Speaker at Congresses of the Cosmetics Industry. For many years associated with the world of chemistry and cosmetology, she deals with the evaluation of cosmetics on a daily basis as a Safety Assessor; with over 5 years of experience in the field of safety and toxicology assessment of cosmetic products, biocides and chemical mixtures.

Business area:

• The toxicological safety assessment of a cosmetic product
• Assessment compliance of the product with regulations
• Substance registration in REACH
• Assessment of compliance of products with the CLP regulation
• Registration of biocidal products
• Assessment of the degree of naturalness of cosmetics (ISO 16128)
• Cooperation with leading Polish cosmetics producers and cosmetic laboratories

Training and certificates:

• Safety Assessment of Cosmetics in UE, Vrije Universiteit Brussel, 2021
• Specialist Course For Safety Assessors, Theta Consulting Poland, 2021
• Safety in the use and management of chemicals, Faculty of Chemistry, University of Lodz, 2018

Lucas is an accomplished clinical trial quality expert with nearly two decades of experience in Good Clinical Practice (GCP) across SMO and CRO environments. With a strong background in leadership and oversight, he has held senior responsibilities in Quality Assurance and Clinical Quality, ensuring that clinical trial activities meet high standards of regulatory compliance, patient safety and data integrity. quality management systems within the pharmaceutical industry. What gives me him unique perspective on this subject is his dual experience - having had the privilege of working both within the Polish Regulatory Authority and on the industry side, collaborating with organizations that plan and conduct clinical trials. This dual background allows him to understand the expectations of regulators while deeply appreciating the practical, day-to-day realities of trial operations.

His expertise includes an advanced understanding of global clinical trial regulations and practical experience overseeing, preparing for and hosting major regulatory inspections, including those conducted by the FDA, MHRA and BfArM. He has worked across multiple quality functions, including Quality Management System development, implementation and maintenance; audit and compliance activities; root cause analysis; and corrective and preventive action planning.

His specialist areas include building and maintaining robust Quality Management Systems, designing annual audit programmes, conducting vertical, horizontal, directed, routine and for-cause GCP audits, managing GCP vendor audits and oversight, and supporting inspection readiness. This breadth of experience enables him to provide practical, regulation-focused insight into clinical trial quality and compliance.

Hello there! I am Marcin, a co-founder of Wsparcie Decyzji, Assistant Professor at the Poznan University of Economics, and a keen scholar with a PhD in Economics. I'm thrilled to invite you on a transformative learning journey on the AIDIFY platform.

Over the past 12 years, I have worked as a trainer, coach, and consultant in corporate strategy, human resources management, and leadership, among other areas. I've conducted more than 1,500 hours of training, coaching, and business consulting, honing the organizational capabilities of dozens of companies from diverse sectors.

As a co-founder and manager of the prestigious 'Master of Business Training' program at the University of Economics in Poznan, I've had the pleasure of guiding elite coaches and postgraduate managers towards professional excellence.

My practical experience, acquired through numerous managerial roles - from the president of the board of directors to a member of the supervisory board - in both manufacturing and service sector companies, enriches my teaching approach. By blending this hands-on knowledge with the latest scientific research and trends, I can deliver practical solutions to your business challenges.

Having co-authored training programs for EU-funded national projects and published more than 35 works in the field of management, I’m eager to share my insights with you.

Join me, and together, we'll explore these exciting topics, empowering you to become an effective leader and manager. Your enriching journey with me begins here!

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.

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

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

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

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.

I am PV specialist, but also PV trainer. I studied biotechnology and I gained master degree in chemical biotechnology - drugs and cosmetics development. After graduation It was important for me to acquire the knowledge about all steps that are involved in the product development from the laboratory to the product being on the market, so during my carrier I took the opportunity to gain experience in different areas like R&D, manufacturing, marketing and educational programs. I’ve started my PV journey about 5 years ago, right now I am Training and Education Manager and my role joins both areas of interest which is PV and education. I am also member of PTBFarm – Polish Polish Society of Pharmacovigilance In my trainings I apply the same approach I have mentioned above – I think that to understand your role better, you need to learn about the entire process and other roles in the “ecosystem”. I always try to arouse interest in individual exploration of presented topic and give you necessary tools. Therefore, I hope to pass on the knowledge in my class but also prompt your further development. See you in the training!

Julia is an enthusiast of Prompt Engineering and Generative Artificial Intelligence. Her fascination with the written word and content creation represents just a fraction of her broad range of interests and expertise. With the emergence of ChatGPT, Julia has plunged into the realm of prompt engineering, exploring groundbreaking techniques and insights from industry pioneers. Leveraging her vast experience, Julia plays a pivotal role in the AI team at Miquido, actively contributing to the creation of cutting-edge solutions that encompass conversational platforms, interactive knowledge bases, and comprehensive IT and HR support systems. Julia not only perpetually expands her knowledge but also passionately shares it, instructing others on how to utilize prompt engineering in data processing, meticulously analyze and test prompts, refine and elevate the quality of conversations, and securely configure and manage ChatGPT systems.

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.

Bartlomiej Ochyra is a seasoned pharmacovigilance (PV) professional with nearly 9 years of experience spanning both clinical and post-marketing environments. He holds a Master's degree in Pharmacy from the Medical University of Lublin and a postgraduate degree in Project Management from the Warsaw School of Economics. Furthermore, he has earned a Ph.D. in Medical Sciences and Health Sciences, with his research focusing on "The Role of Medical Literature in Signal Detection."

Currently, Bartlomiej Ochyra serves as the Associate Director and Affiliate Head of Patient Safety in Poland at a leading global innovative pharmaceutical company. Since May 2023, he worked at Polpharma Headquarters as the Head of Pharmacovigilance Quality Management and Training. In this role, he was responsible for managing the Global PV Quality Management System, which includes conducting PV audits, maintaining standard operating procedures (SOPs), and overseeing global PV training. Prior to his tenure at Polpharma, he dedicated almost seven years to Teva Pharmaceuticals, where he served as the Jr Pharmacovigilance Manager & Local Safety Officer Deputy for Poland. His rich professional journey also includes his current position as the Director of the Training Division at the Polish Society of Pharmacovigilance.

In addition to his professional commitments, Bartlomiej Ochyra is an avid lecturer and educator. Reflecting his passion for innovation and technology, he co-founded AIDIFY, an innovative educational startup. This endeavor highlights his dedication to advancing education in the field of pharmacovigilance.

• Director Deputy of Department for Assessment of Medicinal Products Documentation, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• European Medicines Agency (EMA) expert
• The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) alternate
• Biological Working Party (BWP) alternate

Greetings and welcome to my site!

My name is Paweł Pawłowski and I am quality expert. Currently I am employed at the polish competent authority responsible for registration of medicinal products as deputy director of the Department for Assessment of Medicinal Products Documentation. For several years now I am the EMA expert as well as the CMDh and BWP alternate member.

As you may guess every day we struggle with the aspects concerning regulatory and assessment of the registration dossiers. This is not easy due to the number of guidelines, their dynamic updates, views changes of the European medicines regulatory network and the fact that many aspects are considered on case by case basis.

It is thus completely understandable if you are keep looking for additional information or just want to consolidate the acquired knowledge. In fact, continuous learning is essential for professional success in this field and best of experts learn all the time. And you should remember, that this is the process. You will not be magnificent expert and easily navigate in the quality field after less than few years work and just after one or two courses. So do not worry, if you find something difficult or incomprehensible from the very beginning. I hope that the AIDIFY platform will help us all go forward and exchange our experience, views and knowledge. I am happy that I can be part of it!

Good luck and please remember, that if you have some questions or opinions, do not hesitate to ask or comment.

She has been involved in the clinical research industry since 2015. She currently works for a global pharmaceutical company as a Manager in the Clinical Documentation team, where her main role is FSO Operations Lead.

She places high value on personal development and the quality of performed activities, which makes her a valued member of project teams. She has operational experience gained in global CROs and pharmaceutical companies. She has worked on both investigational and medical device projects in a variety of therapeutic areas.

From the very beginning of her work in clinical research, she has struggled with the complex nature of clinical trial documentation and TMF, which she continues to explore to this day.

In addition to her day job, she is actively involved in the academic community, initially as a coordinator and support to the manager of a post-graduate study in the clinical trial area. Currently, she is a lecturer at Conducting and Monitoring Clinical Trials and Associate Director in Third Party Processes & Operations.

This collaboration started after the previously completed postgraduate studies in Conducting and Monitoring Clinical Trials. Graduate of Nicolaus Copernicus University in Torun in the faculties of molecular biology and environmental protection.

Although she started her professional life at the Central Forensic Laboratory of the Police, she now finds herself perfectly at work in clinical project activities and now she is conducting other types of investigations.

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.

Agnieszka is graduated from Faculty of Biology, University of Warsaw, where she also had continued research study earning PhD in Molecular Biology. Mastering the knowledge in life science field and developing transferable skills helped her in clinical research field. Currently, she is a GCP Expert with over 15 years of experience in clinical research as a Contract Research Associate, Trainer and Clinical Quality Manager. Responsible for inspection readiness activities, inspection preparation, facilitation and follow up. Participated in several on-site or remote FDA, EMA and local Health Authority inspections as well as in number of audits when working for CROs or pharmaceutical companies. Actively involved in in-dept root cause analysis of the audit or inspections findings, effective CAPA plans preparation, their follow up and effectiveness check.

Agnieszka is process-oriented, especially in terms of the processes at the site level, as she believes that a good set up of the investigational site for clinical trial is indispensable to its success.

As a member Training Section of the Association for Good Clinical Practice in Poland (GCPpl), she promotes knowledge about clinical trials and ICH GCP in the medical and pharmaceutical industries and likes sharing experience with others.

My name is Maciej Szewczyk and I'm CEO of MS Pharm company – pharmacovigilance provider fully dedicated to deliver Medical Literature Monitoring solutions to pharma industry, with strong focus on publications which are not easily reachable – means published locally and in native languages. I'm involved in this area of pharmacovigilance from 2009 on the different positions, from the project management, through business development including designing of dedicated MLM tools to CEO of company which currently manage over 130 MLM projects and cover over 1000 locally published medical and pharmaceutical journals.

I’m very lazy person in that way, that I’m always trying to automatize or at least maximally simplified all repeatable processes. That’s why we develop dedicated MLM tools which allow us to effectively manage projects we are responsible for.

I like to project and involve in development of software, which will make our life easier and more efficient. I love playing with numbers and statistics, that’s why I was involved in preparation of few analysis regarding literature in pharmacovigilance, e.g.

• “Impact of literature reports on drug safety signals”
• “Identification of information about adverse drug reactions in local medical journals using Medline and Embase versus manual full text review”
• “The drug safety information in domestic medical literature”

I’m also member of Polish Association of Pharmacovigilance and I was involved in creation of Literature Standard of Polish Association of Pharmacovigilance, which was published in Almanach of Polish Regulatory Authority - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Privately my biggest passion is badminton, skitouring and MTB.

Excellent communicator with can-do attitude and strong desire to learn. Project Manager with line management responsibilities focused on quality. Currently fulfilling the role of an Oversight Portfolio Manager working on a governance level, responsible for several studies of one client and oversight and support a group of CTMs allocated for those projects. Client oriented and dedicated team player. Long-term goal is to have an independent and responsible position as a global project director. Experience in pharmaceutical marketing, medical affairs and clinical trials gained in pharma companies and CROs.Founder and member of Polish Pharmaceutical Students’ Association. Member and head of the training group at Polish Association for Good Clinical Practice (GCPpl). Pharmacist with strong interest in clinical pharmacy. Academic teacher delivering lectures related with clinical trials.

Certificates: Soft Skills Trainer Certificate, Prince2 Foundation Training Certificate, Barnett GCP Certificate. Laureate and winner of a 3rd place of the national competition “Leaders of Clinical Trials (2021)” in the category Project Manager. Scholar of Leslaw A. Paga Foundation in the program “Healthcare Leaders”.

Privately foodie and enthusiast of cooking, travelling and fantasy books.

Pharmacist. Graduated at Warsaw Medical University. Ph.D. in 2010.

Since 1996 dedicated to the regulatory area in Poland. At first as post-autorisation variations’ specialist, later as clinical trials and pharmacovigilance specialist at National Drug Institute.

Involved in Pharmacovigilance legislation implementation in Poland between 2010-2013.

Lecturer in different training courses in Poland and during local and international conferences in regulatory and pharmacovigilance area.

Holds certificate in EVDAS (EudraVigilance Data Analysis System) and EV (Eudravigilance) ADR Reporting.

Loves music, trying to learn being a drummer (since 2016). Knitting especially during long winter evenings. Taking care of dear Son and cat.

I am Karolina Wawrzyniak and I am a Country Patient Safety Manager at pharmaceutical company. In my daily work I deal with the broadly understood risks associated with administration of a medicinal product and benefit/risk balance. For this reason, I mostly specialize in creating Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Benefit/Risk Analysis and Safety Monitorings. I prepare reports for both the European and Eurasian countries. Furthermore, I specialize in additional risk minimization measures (aRMMs). I take part in many projects related to aRMMs - plan, implement and supervise educational materials and programs (e.g Pregnancy Prevention Programme), coordinate projects related to the switch of the drug legal status, conduct trainings related to risk minimization, cooperate with healthcare professionals, representatives of Competent Authorities, opinion leaders, medical experts and contractors. Additionally, I supervise the processes related to Safety Data Exchange Agreement (SDEA), I cooperate with lawyers and many business partners around the world. Moreover, I am also active in the field of clinical trials – I prepare Development Safety Update Reports (DSURs), supervise the list of clinical and non-clinical trials and I am responsible for collecting and verification of documentation from clinical trials.

I graduated from the Medical University in Łódź in the field of Pharmacy. After 5.5 years of study, I did a six-month internship in community pharmacy, after which I became a Master of Pharmacy. My adventure with the PV department began with an internship in a pharmaceutical company, after which I got the position of a Specialist and then was promoted to the Senior PV Specialist. But already during college I participated in many courses in the field of Pharmacovigilance, Regulatory Affairs and Clinical Trials:

• Introduction to clinical trials
• Introduction to Pharmacovigilance
• Pharmacovigilance – Professional Level of Training
• Principles of Regulatory Affairs for medicinal products, veterinary products with elements of pharmacovigilance management & Documentation for medicinal and veterinary products
• Introduction to collecting and reporting adverse events in clinical research
• Data safety and monitoring boards for clinical trials
• Pharmacovigilance Specialist at Pharmaceutical Company

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

My professional career includes holding the position of Medical Director in the local affiliates of pharma companies of global reach for several years. On top of other ones, my duties included oversight of local pharmacovigilance processes. As part of it, I was responsible for the setup and the oversight of the local medical literature activities. Being in the role of Drug Safety Officer or the deputy of the DSO for all those years, I had not only the chance to manage this area but also to translate the organizational frames into the daily pharmacovigilance activities in order to be certain the requirements as set out by the GVP are met. As the medical doctor with past academic experience, I am also able to understand the way the medical publications are edited, which adds to the ability to understand the unspoken information in the articles.

For the last 4 years, I have been being involved in supporting the local medical literature monitoring processes at MS Pharm s.r.o., a Czech-based company focused on providing the literature monitoring services. This tenure allows me to further expand my experience by confronting my understanding of the GVP requirements with the stakeholders in the pharmacovigilance area across the pharma industry. Looking at the literature monitoring from a number of different perspectives, it allows me to collate their experiences with these of mine in order to come up with the solutions that fit to the MLM best.