International Scientific Conference
"Emerging Trends in Registration and Reimbursement of Pharmaceuticals 2005-2010"
Cultural Center of the Barnabite Fathers
1, Smoluchowskiego St., Warsaw
January 13-14, 2005
Conference agenda includes:
Prof. Rolf Bass, Dr Johannes Lütz - Bundesinstitut für Arzneimittel und Medizinprodukte (BfArm), Germany,Ministry of Health, Poland
Update of marketing authorisations in Poland, How to manage the update of the "Old Market"
Truus Janse-de Hoog, John Lisman - Medicines Evaluation Board, Netherlands
MRP repeat use procedure in new MSs, Review 2001 and Generics, the most important changes for MRP / DCP
Dr Waldemar Zieliński, Awafarm s.c.
New Pharmaceutical Legislation: Poland and European Union
Christian Gericke, MD, MSc, DTMH - Dept. of Health Care Management, Berlin Technical University
Current Trends in Health Care and Reimbursement Systems in Europe
Imre Boncz, MD, MSc(Rotterdam) - National Health Insurance Fund, Budapest
Formulary Development and Reimbursement System in Hungary
Prof. dr hab. Tomasz Hermanowski - Advanced Management Training Program in Pharmacoeconomics, Pharmaceutical Marketing and Law - Warsaw University of Technology Business School
How to manage drug benefit without government-regulated prices and lists of reimbursed drugs? Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003
Adv. Ewa Rutkowska - International Law Firm Lovells
EC law on reimbursement of medicinal products
Panel discussions, including invited representatives of the Ministry of Health, registration authority, National Chambers of Physicians and Pharmacists and pharmaceutical industry
Why is makes sense to take part:
Participation in the Conference can bring benefits to firms and delegates, whose activity is based on knowledge of following problems:
- New pharmaceutical law in European Union
- Expected changes in Polish pharmaceutical legislation
- New attitude to marketing authorisaton of generic medicinal products medicaments and those of well established medicinal use
- Procedure of Mutual Recognition and expected changes in this procedure
- How "new" Member States operate in the framework of Mutual Recognition Procedure
- How to conduct the procedure of documents "update"
- How other registration agencies are implementing the procedure of documents "update"
The Conference will help participants to:
- Understand better existing and considered basic options, regarding healthcare funding and allocation of resources in European Union
- Determine the efficiency and equity implications (justice, access to service) of different reimbursement mechanisms
- Describe how newer developments in healthcare organization and management in Europe affect reimbursement of healthcare technologies
- Learn about innovative rules of medicaments' reimbursement, being implemented in USA within the framework of the greatest reform of MEDICARE program in history
- Find out, what is happening in Hungary in relations between public payer and pharmaceutical manufacturers, and what problems face National Health Insurance Fund in this country
- Explain the consequences of implementation of government regulated prices of drugs, up to now purchased by Polish hospitals by public tenders
- Hear opinions of distinguished Polish and international experts on expected changes in drug registration and reimbursement systems in United States, "old" and "new" European Union states and in Poland and understand the point of view of representatives of registration authority, Ministry of Health and National Health Fund
- Take part in discussion, regarding proposed MOH ordinance, which would oblige medical doctors to use only international names in prescribing medicaments
- Ask questions and express
Objectives of the Conference:
Objectives of the Conference:
- New pharmaceutical legislation in European Union and consequences for facilitation marketing authorization of generic medicinal products and those of well established medicinal use. For firms which are planning use of Mutual Recognition Procedure - it would be an opportunity to establish direct contacts with representatives of Dutch Agency, which in the second half of 2003 was leading the Mutual Recognition Facilitation Group Facilitation Group.
- Experiences of German Registration Agency (BfArM), which cooperates with Poland within the framework of Phare-Twinning project (Poland/Germany),. It will be possible to discuss the most crucial problems, and hopefully, what could be an important achievement of the Conference, to draft a list of suggested activities.
- Evolution of healthcare system, rules and technologies of drugs reimbursement and their impact on competition between pharmaceutical companies, distributors and other subjects which operate at drugs market.
- Changes which are happening in the environment of pharmaceutical industry - knowledge of those changes is essential for efficient management and strategic planning, especially when working on marketing plans and Business Plan for 2005-2010.
Who should attend the Conference:
- Managers, responsible for registration and reimbursement of drugs, working in pharmaceutical industry, it's surroundings and service organizations, National Health Fund executives in charge of drug benefit administration
- Executive and non-executive directors of companies, operating on the pharmaceutical market
- Senior staff from Medical, Strategic Planning, Business Development, Sales and Marketing Departments, Product, Key Account and District Managers
- All who are engaged in the process of planning corporate business strategy and development of Business Plan and Marketing Plans
- Managers responsible for Communication and Public Relations
- Government Relations Department executives
- PSenior staff from advertising agencies, media and promotion experts, market and opinion research companies, serving pharmaceutical sector
- RLegal counselors and advocates, specializing in pharmaceutical legislation
- Consultants, working for pharmaceutical industry
- Members of the Academia, interested in social policy, healthcare management and organization, pharmacoeconomics and pharmaceutical care
||13th - 14th January 2005
||8:00 - 10:00 a.m.
|Participants receive copies of presentation slides, printed in information materials format
|Polish, simultaneous translation in English
|Conference participation fee: 3.600 PLN + VAT,
Participation fee for one day of the Conference: 2.000 PLN + VAT
Conditions of participation:
Participation fee for one person - full two-day program of the Conference - 3.600 PLN + VAT; Participation fee for one day of the Conference - 2.000 PLN + VAT.
Participation fee includes: Conference attendance, Conference materials, lunch and coffee breaks.
Following the receipt of a signed registration form, a confirmation of participation and a pro forma invoice will be sent.
Payment of participation fee should be executed within 7 days, but not later than January 12, 2005, to:
SOPHARM Sp. z o.o.,
Account number: 76 1240 1112 1111 0000 0165 1522,
Bank PKO SA VIII O/Warsaw
RCancellation of participation should be sent by fax or registered letter to organizer's address. Lack of payment is not equivalent to cancellation. Failure to cancel the application or no-show at the Conference will cause charging of full participation fee.
In case of cancellation before January 7th
, 2005 , we will charge a handling fee of 360 PLN + VAT.
In case of cancellation after January 7th
, 2005, full participation fee will be charged.
Instead of the person registered for the Conference, another employee of the same company may be substituted.
Organizers reserve the rights to change program details and/or date of the conference.
Additional information on the Conference may be obtained from:
Dr n. farm. Anna Biel-Zielińska, AWAFARM s.c., phonel: +48 (22) 831 06 75,
mgr. Joanna Zaorska, phone: +48 0605 031 668,
Participants may register for the Conference by sending the registration form by fax to the following number:
+48 (022) 857 57 60
or by letter to the following address:
SOPHARM Sp. z o.o., ul. Bełdan 4/52, 02-695 Warsaw
( files to download ):
Under the scientific patronage of
Warsaw University of Technology, Business School: