Startdate:
19 May 2010 - 21 May 2010 Purpose:The programme will concentrate on EU Product Life Cycle Activities, and will provide an update on the latest regulatory requirements, e.g. the new EU variation legislation and guidelines and paediatric regulation, however also give a brief insight on differences across regions, e.g. EU, US and Japan. During the 3 days you will meet very experienced speakers with significant competencies in the different regulatory disciplines both from Competent Authorities and Pharmaceutical Industry. Learning will be enhanced through interaction with the other participants, while working in groups on a case story, illustrating the considerations to be made for the different opportunities and issues arising during the life cycle of a product. All together this module will give you a good base of knowledge relevant to regulatory advice on the possibilities and consequences for different types of Life Cycle Activities and enable you to make the strategies, do the planning and perform the activities related to the regulatory maintenance of the product in your every day working environment. Content:Life Cycle Management, type IA & IB Variations, type II variations, new variation legislation, various line extensions (new strengths, new indications, new dosage form, new groups of patients), safety updates, risk management plans, scientific advice, renewals, referrals, paediatrics, alerts, outside dictated changes, change control systems, data protection etc. Areas that among others will be covered:
Product Life Cycle Activities from a Business Point of View Type IA & IB Variation Type II Variation Industry View on New Variation Legislation Regulatory Considerations for Quality by Design Differences in Regulation - USA/Japan/Rest of World – seen from an European Point of View Change Control System and Regulatory Compliance New Indications and Extensions Renewals Intellectual Properties and Generic Competition Generic Product – Regulatory Considerations and Strategy Paediatrics Patient Leaflet and Labelling Requirements Risk Management Plans Safety Changes to the SmPC SmPC Harmonisering Referrals Experiences from “real-life” Ian Talmage
Senior Vice President, Bayer Schering Pharma AG, Germany Hilde Boone
European Medicines Agency Liason Official at the US, FDA, Washington DC, US Carole Murcott
Senior CMC Expert – Global Advisor, Novartis Pharma AG, Switzerland Karen FichHead of Section, Regulatory Affairs - CMC; H. Lundbeck A/S, Denmark Sonja HorstedSenior R&D Project Manager, LEO Pharma A/S, Denmark Mikael SørudDirector, Regulatory Affairs, Novo Nordisk A/S, Denmark Anna Bartosik
Head EU Regulatory Maintenance, Novartis Pharma AG, Switzerland Malene Metz Moerch
Head of Drug Regulatory Affairs and Quality, Sandoz A/S, Denmark
Anne Althoff
M.D.R.A., Federal Institute for Drugs and Medical Devices (BfArM), Germany
Dr. Harald Tietz
Director, Global Patient Safety & Regulatory Affairs, Lilly, Germany Janne Malene Kampmann
Head of Section, Neurology Section, International Safety and Pharmacovigilance, H. Lundbeck Mette Maxmølris
Head of Section, Products and Labelling, Regulatory Affairs, H. Lundbeck A/S Denmark
Hanne Brokopp
Director - Regulatory Affairs Europe, Merck, Sharp & Dohme (Europe), Belgium Pilar CarreroSafety Medical Writing Group Team Leader at the Dept. of Safety Surveillance Diabetes, Novo Nordisk A/S, Denmark
Emilie Niedercorn
Senior Manager, Regulatory Affairs Europe, Merck, Sharp & Dohme (Europe), Belgium Target:
This module is aimed at regulatory employees who would like to get a better understanding of the regulations and legal framework having an impact on Product Life Cycle Management, and on how to apply this on regulatory Product Life Cycle Strategies. Prerequisites:In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt. Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis. Literature:A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module. The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus. The participants are expected to study and be familiar with the mandatory references in advance of the module. |
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Price:DKK 17,000.00 (approx. EUR 2,285.00) + VAT 25%, included: course fee, meals during the days, coursematerial, networking dinner Exam fee DKK 1,500 (approx. EUR 202) Any cancellations must be in writing to Medicademy. From 1 month to 14 days prior to the course, a charge of 10 % of full course fee per order.. From 14-8 days prior to the course, a charge of 50 % of full course fee per order. 7 days prior to the course and later it would no longer be possible to refund the course fee. If you are unable to attend, you are of course free to assign your seat to a colleague. You just have to inform Medicademy in writing. If Medicademy cancels a course, Medicademy refund the course fee in full. In case of circumstances outside the control of Medicademy, Medicademy reserves the right to change the program, teachers, date and location. Registration deadline:
12 May 2010 Exam:Date of examination: TBD You can take the examination in your own country! Medicademy arranges examinations at Embassies, Universities etc. all over the world. Information about examination form etc. will follow. Remember to register for the exam separately! |
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Register:
DKK 17,000.00
VAT, 25% DKK 4,250.00
Incl. VAT DKK 21,250.00
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