Startdate:
1 September 2010 - 3 September 2010 Purpose:During the 3 days the participants will interact with the expert lecturers and will work with case stories in smaller group sessions to illustrate the necessary considerations for the different types of applications. The module will give you a solid basis for evaluating the opportunities and consequences related to different types of products and submissions and subsequently to plan and operate within the frame work of the various application procedures. Module 2 will also be an essential basis for the modules concentrating in more details on the Quality, Safety and Efficacy aspects or on strategic considerations as well as the modules covering th requirements in other parts of the world. Content:Whereas Module 1, "The Pharmaceutical Law Frames in the EU" provides knowledge of the pharmaceutical legislation in the EU, Module 2 "Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation" focuses on the implementation of this legislation, e.g. on the procedural and operational aspects when applying for marketing authorisations, clinical trials and orphan drug designations in the EU. In addition you will learn how to comply with the EU requirements for paediatric investigation plans, risk management plans as well as how to obtain scientific advice from EU authorities. Areas that will be covered:Marketing Authorisation Applications – Overview, Terminology and OrganisationRoles and responsibilities: the Commission, EMEA, National Competent Authorities Types of application Procedures EU vs. the rest of the world Applications for New Medicinal Products
Legal basis Content and format Fixed combination products Drug-device combinations Applications for Generic and Similar Biological Medicinal Products
Legal basis Data protection Content and format Well-established medicinal use Challenges and opportunities (case stories) The Centralised Procedure – EMEA PerspectiveCentralised Procedure (role of EMEA, eligibility, pre-submission dialogue, procedure for filing application, fees, selection of rapporteurs, timelines, operational aspects, pros/cons, appeal procedure) Accelerated procedure, conditional approval, exceptional circumstances Transparency The Centralised Procedure – Industry PerspectivePros and cons Challenges and opportunities (case stories) Scientific Advice from CHMP and National Competent AuthoritiesWhy, when, how and where to apply for scientific advice National vs. CHMP advice, pros and cons Protocol assistance Pre-submission EU/US co-operation Orphan Medicinal Products
Legal basis Opportunities (market exclusivity) and limitations Small population guideline Procedure for obtaining designation Timelines and fees Post-approval obligations Transparency Annual reports EU/US – differences and similarities Clinical Trial ApplicationsLegal basis Content and format EUDRACT IMPD quality guideline Procedures, timelines, submission to regulatory authorities and ethic committees (role and responsibility) Substantial amendments Annual Safety Report End of Trial Notification First-in-human clinical trials Risk ManagementThe Risk Management Plan Content and format Timing and resources RMP data base Scientific assessment Conditions and restrictions Post-marketing updates Paediatrics – Authority PerspectiveLegal basis PDCO PIP, waiver, PUMA Format and content Procedures Paediatrics – Industry PerspectiveTiming and resources Templates Challenges and opportunities (case stories) E-ApplicationseCTD, format and content – demonstration EUDRACT System requirements Challenges and opportunities New Applications in the Decentralised/Mutual Recognition ProcedureTypes of products Filing the application Fees Selection and role of RMS Timelines Granting of national authorisation Operational aspects Referrals Experience Transparency DCP/MRP – Industry Perspective
Pros and cons Challenges and opportunities (case stories) Line Extension and Variation ApplicationsTypes of application Content and format The new variations regulation Scope and status Downgrading, pooling and consequential changes Status of supporting guidelines Renewal and Deregistration Product InformationReadability testing Translation - David Jones, Senior Pharmaco-Toxicologist, Licensing Division, MHRA, UK
- Thomas Girard, European Medicines Agency, UK
- Pilar Carrero, Safety Medical Writing Group Team Leader at the Dept. of Safety Surveillance Diabetes, Novo Nordisk A/S, Denmark
- Dr. Anja Langeneckert, Group Leader for Early Development, F.Hoffmann-La Roche Ltd., Switzerland
- Dr. Bao Phan, Roche, Switzerland
- Dr. Sandy Dickin, Principal Regulatory Consultant, Eli Lilly and Company, UK
- Dorte Jensen, Manager Regulatory Affairs, Actavis, Denmark
- Truus Janse-de-Hoog, The Medicines Evaluation Board (MEB) in the Netherlands, responsible for the the Mutual Recognition Procedure and chair of the CMD Group, The Netherlands
- Dr. Marén U. Koban, Regulatory Affairs Manager, Nycomed Deutschland GmbH, Germany
- Mette Maxmølris, Head of Section, Products and Labelling; Regulatory Affairs, H. Lundbeck A/S Denmark
- Dr. Harald Tietz - Director Global Patient Safety and Regulatory Affairs, Lilly, Germany
- Karen Tornøe, Danish Medicines Agency, Denmark
- Nanna Aaby Kruse, M.Sc.Pharm, Senior Biological Assessor, Member of BWP, Danish Medicines Agency, Denmark
- Mette Maxmølris, Head of Section, Products and Labelling, Regulatory Affairs, H. Lundbeck A/S
- Anders Gerner Petersen, Nordic Regulatory Affairs Manager, Genzyme, Denmark
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. |
|
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:
25 August 2010 Exam:Date of examination: October 4, 2010 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! |
|
Register:
DKK 17,000.00
VAT, 25% DKK 4,250.00
Incl. VAT DKK 21,250.00
|
|