• 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.

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