MBR Consulting S.C. Team:

Małgorzata Brodzka-Raszek, MD

Graduated from the Medical Academy in Warsaw in 1981. During time working in the Department of Anaesthesia and Intensive Care, University Hospital, achieved the status of Consultant in Anaesthesia and Intensive Care in the Academy. In 1989 became Head of the Intensive Care Unit.

International experience working as a Registrar in Anaesthetics at an acute hospital in the UK as well as a Lecturer and Consultant in Anaesthesia in the Netherlands.

In 1993 appointed Medical Director of Zeneca, and later on, AstraZeneca in Poland. In this capacity responsible for both scientific and commercial activities maintaining and developing contacts with key opinion leaders, as well as senior officials in the Ministry of Health and the Kasa Chorych (National Health Found). Responsible for extensive Phase II to IV International Clinical Trials in Poland in various therapeutic areas, including oncology, neurology, psychiatry, asthma, anaesthesia, infections (1000 patients per year).

In 2000 established own consultancy business in Poland, MBR Consulting, providing Regulatory services to the pharmaceutical industry.

In 2002 established second business, CRO Poland Ltd, providing Phase I to Phase IV clinical Trial services.

Summary of relevant training received: several GCP/ICH trainings, Protocol Writing, Marketing Diploma, Selling Skills, Negotiation Skills, Presentation Skills, Recruitment and Selection, Interpersonal Skills, Change Management, Managing People/Coaching Skills, Time Management, Project Management, Writing winning proposals, Evidence Base Medicine, Health Economics. Extensive professional experience and knowledge in various aspects of the pharmaceutical market in Poland as well as international environments, extensive clinical trial experience in various therapeutic areas, managerial experience, training and coaching experience.

Strengths – strategic thinking, skills transfer, effective communication, results orientation, flexibility, process and interpersonal awareness, self confidence, concern with impact, gaining commitment.

Jerzy Raszek, MD

Graduated in 1975 from Warsaw Medical University; Specialist in Anaesthesia and Intensive Care.

1976-1993 National Paediatric Hospital (Child Health Centre), achieved the position of senior consultant, Head of Anaesthesia Unit;

International medical practice: 1977- Registrar in Anaesthetics, Brussels, Belgium;

1982 - Registrar in Anaesthetics, Rotterdam, Netherlands;

1985-1990 – lecturer and consultant in anaesthesia, contracted by Ministry of Health, Republic of Algeria;

1993-1995: Upjohn Pharmaceuticals, Product Specialist responsible for product placement and KOL direct marketing;

1995-1996: Sanofi Poland, Product Manager;

1996-1998: Bayer Pharmaceuticals, Manager, Product Marketing;

1998-2000: Gedeon Richter Poland, Business Unit Manager, responsible for overall activity and sales results of the team;

2001-2002: Pharm-Olam Int., Clinical Trials' Monitor (CRA).

Since February 2003 appointed as Head of Clinical Unit, CRO Poland Ltd and Marketing Director, member of the Board Extensive clinical trials' managing experience, marketing and sales skills, responsibilities – overall supervision on day-to-day practice of Clinical Trial Unit, market research and analysis, contacts with potential partners for trade contracts.

Piotr Niewiadomski, MD

Graduated from the Medical Academy in Warsaw in 1995 and he completed his Internship in Bielany Hospital in Warsaw. He joined in 1997 Ivoclar-Vivadnet Polska Sp z o.o., working in the same time in the Department of Anaesthesiology, Bielany Hospital, Warsaw.

In 1999 he started his career in was AstraZeneca Medical Department. In this capacity he worked as Clinical Research Associate, Medical Advisor for anaesthesiology range, than he was appointed as Regulatory Officer and, than, as Regulatory Team Manager. He was also nominated as Project coordinator for an Website Development.

In 2007 he was appointed as Medical Director, being responsible for the management of the Medical Department (Medical Advisors, Regulatory Team and Patients Safety), Medical support for marketing, sales and market access, approval of all promotional activities in AstraZeneca (Nominated Signatory function), non-interventional study and Phase 4 studies, and for pharmacovigilance activities in Poland.

In 2011 he joined MBR Consulting S.C. Team, and is responsible for a number of regulatory activities and Pharmacovigilance services to the pharmaceutical industry.

Summary of relevant training received: Project management, team management, soft management skills, time management, regular (on annual basis) Pharmacovigilance training, several regulatory trainings in national and EU procedures, change management, promotional material approval.

Extensive professional experience and knowledge in various aspects of the pharmaceutical market in Poland as well as international environments, training and coaching experience.

Anita Wasiak, MD

Graduated from the Medical Academy in Warsaw in 1993. During time working in the Department of Anaesthesia and Intensive Care, District Hospital, in 1997 achieved a Degree in Anaesthesia and Intensive Care.

In 1998 appointed as Sales Representative in Sanofi-Synthelabo Sp. z o.o, and later on as Specialist Marketing Representative in GSK Commercial Sp. z o.o.

In 2006 she joined MBR Consulting S.C.. She works as Senior Regulatory Consultant, providing Regulatory services to the pharmaceutical industry, dealing primarily with new regulatory submissions in National as well as MRP/DCP submissions.

Summary of relevant training received: Professional Sales Techniques, Presentations, Assertiveness, Various Trainings organized by Bureau of Medicinal Product, Medical Devices and Biocides (Pharmacovigilance, Pharmaceutical Law), Procedures related to the Variations – update, new regulations, Arbitrary Procedures in EU, Current Regulations related to the National Text Approval.

Strengths – strategic thinking, effective communication, results orientation, flexibility, process awareness, self confidence, concern with impact.

Anna Grot, MD

Graduated from the Medical Academy in Warsaw in 1995. After her Internship in Bielany Hospital in Warsaw, achieved the status of Assistant in Anaesthesia and Intensive Care.

In 2000 she was appointed as Regulatory Affairs Manager Astra Sp. z o.o., and later on, Senior Regulatory Affairs Manager AstraZeneca Pharma Poland. In this capacity she was responsible for regulatory and medical projects including pharmacovigilance, contacts with senior officials in the Ministry of Health and Polish Regulatory Authorities.

In 2009 she joined MBR Consulting S.C. Team, and is responsible for a number of regulatory activities and Pharmacovigilance services to the pharmaceutical industry.

Summary of relevant training received: BIRA Introductory Course, Dossier upgrade according to EU requirements, organized by Polish Regulatory Authorities, New Amendment to the Pharma Law – impact on tax and legal position of pharma business in Poland, Regulatory Affairs in the context of the European Union Enlargement, Accession treaty role to Pharmaceutical Industry, EU Enlargement 2004, international conference, speaker "Accession to EU challenge to Regulatory Affairs In Acceding Countries", Austrian Pharma Forum, 5Th PEFRAS Symposium - Nearing the EU Enlargement – Drug Regulatory Hot Topics, Rapid Alert System and Pharmacovigilance, Competition in Pharmacy, Team leading and motivation, Safety of Pharmacotherapy, Pharmaceutical Law update, Certified Regulatory Affairs, Regulatory Summit 2009.

Extensive professional experience and knowledge in various aspects of the pharmaceutical market in Poland as well as international environments, training and coaching experience.

Katarzyna Olszaniecka-Jeżewska, MSc

Graduated from Warsaw University of Technology in Warsaw.

Initially, she joined in 3M and next Saint Gobain working as a Sales Manager.

In 2007 she completed CRA Training Course "An Introduction to Clinical Trials Monitoring" accredited by Polish Association for Good Clinical Practice.

In 2008 he joined MBR Consulting S.C. Team, and is primarily responsible for regulatory submissions of the post-approval variations, working as Regulatory Consultant.

Summary of relevant training received: MRP, DCP variation. Requirements and Profits. 

Strengths – strategic thinking, skills transfer, effective communication, results orientation, flexibility, process and interpersonal awareness, self-confidence, concern with impact, gaining commitment.

Grażyna Stachyra, MSc

Graduated from Medical Academy in Lublin, 1995 from the Nursing Faculty;

Graduated from Medical Academy and Economy Academy in Poznań, 2000, faculty of Management in Health Services;

Graduated from University of Warsaw, 2002, Postgraduate Faculty of Health Economics;

After completing her Nursing Faculty she was employed in Psychiatry and Neurology Institute in Warsaw and later on, in Paediatric District Hospital, Niekłańska St. in Warsaw as a nurse. Since 1998 to 1999 she was employed by National Board of Nurses as Assistant and was responsible for supportive activities to Nursing Court. Since 1999 to 2000 she started her career with Ministry of Health and Social Welfare as Senior Specialist. During that time she was responsible for transformations of Clinical Units; In 2000 – 2001 she was appointed as Chief Specialist in Controlling System at Polish Administrative Unit (Powiat). In 2001 – 2002 she started her career as Chief Specialist of Training Department at National Union of Sick Founds.

Grażyna is experienced clinical nurse and has strong background in managing and training medical staff.

In 2003 she joined MBR Consulting, and is responsible for daily contacts with QRD  Department.

Urszula Krawczyk - Ph.D., M.Pharm

Graduated from the Pharmaceutical Faculty, Medical Academy in Warsaw, she completed her Ph.D. in Hungarian Academy of Science, Semmelweis University in Budapest, Hungary.

Independent expert and auditor, with a scope of activities as follow: GMP audits (product audit, process audit, supplier audit), Quality Assurance consulting, registration dossier CTD format Module 3 Quality, Module 2 Overall Quality Summary.

Her past experience covers Drug Institute, Laboratory of Alcaloids and Cardiac Glycosides; Department of Chemical Analysis, position of the Head of the Laboratory of Herbal Medicines, Drug Institute, Department of Herbal Medicines and Plant Materials; European Pharmacopoeia, observer in the group of experts No.13; Drug Institute, Head of the Division of Quality Systems Evaluation, Director's Plenipotentiary for Quality Assurance; observer in the Ad Hoc GMP Inspectors meetings, EMEA, PanEuropean Regulatory Forum (PERF) for Central and Eastern European countries (CADREAC); co-chairman in the GMP Inspections Group; National Institute of Public Health (former Drug Institute), Head of the analytical department (chemical analysis, medicinal product dossier assessment);

Summary of relevant training received: she completed a number of Pharmaceutical Inspection Convention / Pharmaceutical Inspection Co-operation Scheme (PIC/PICS) Seminars; full training record available at request.

Extensive professional experience and knowledge in QA aspects, GMP, GLP, as well as Chemical&Pharmaceutical Part of the dossier.