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Medicademy Module R2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation
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Registration deadline:
8 August 2012 Exam:Date of examination: October 8, 2012 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. |
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Register:
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Startdate:
5 September 2012 - 7 September 2012 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. By the end of this module, the student should be able to:
- understand the EU regulatory framework, the various types of applications and procedures, i.e. clinical trial applications, procedures for obtaining scientific advice, the types of marketing authorisation procedures – including the centralised procedure, the decentralised procedure, and the mutual recognition procedure, applications for new medicinal products, generic and similar biological medicinal products, line extensions, and variations applications, renewals and deregistrations, orphan medicinal products, paediatric investigational plans, risk management, and product information
- analyse the overall strategic choices for the regulatory procedures used during development, application, and maintenance of the medicinal product
- evaluate the opportunities and consequences related to different types of products and submissions, and subsequently to plan and operate within the framework of the various application procedures
- use best practice, when handling various applications and procedures (see above), and in interactions with the European Authorities Download Flyer Course Leaders:
Katrine Damkjær Madsen, Danish Medicines Agency, Denmark Eva Maiken Holck, Regulatory Affairs Manager, Novartis Healthcare A/S, Denmark Lecturers:
Dr. Harald Tietz, Director Global Patient Safety and Regulatory Affairs, Lilly, Germany David Jones, BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, MHRA, UK Marie Valentine, Regulatory Adviser, EMA, UK Sandy Dickin, BVSc(Hons) PhD MRCVS, UK and ROI Regulatory and Drug Safety Manager, Lilly, UK Jenny Kastberg, Senior Safety Medical Writer, Global Safety, Novo Nordisk A/S, Denmark More international lecturers will be added... 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.
Marketing Authorisation Applications – Overview, Terminology and Organisation
• Roles and responsibilities: the Commission, EMA, National Competent Authorities
• Types of applications
• Procedures
• EU vs. the rest of the world
• Legal basis
• Content and format
• Fixed combination products
• Drug-device combinations
• Generic and biosimilars
• Well-established use
The Centralised Procedure – EMA Perspective
• Centralised Procedure, role of EMA, eligibility, procedure for filing applications, rapporteurs, timelines, pros/cons
• Accelerated procedure, conditional approval, exceptional circumstances
• Transparency – including EPARs and EMA publications
Scientific Advice from CHMP and National Competent Authorities
• Why, when, how and where to apply for scientific advice
• National vs. CHMP advice, pros and cons
• Pre-submission
• EU/US co-operation
Orphan Medicinal Products
• Legal basis
• Opportunities (market exclusivity) and limitations
• Procedures for designation
• Timelines and fees
• Post approval obligations, transparency
• EU/US differences and similarities
New Applications in the Decentralised/Mutual Recognition Procedure
• Types of products
• Filing the application
• Selection and role of RMS (national procedures included)
• Timelines
• Granting of national authorisation
• Operational aspects
• Referrals
• Experience
• Transparency
DCP/MRP – Industry Perspective
• Case story of a referral
Risk Management
• The Risk Management Plan
• Content and format
• Timing and resources
• Planning and writing RMPs
• Challenges and considerations related to the RMP
• Regional differences in risk assessment
• Compliance and enforcement
• Regulator’s expectations
New Pharmacovigilance Legislation
Clinical Trial Applications in a Pan-European View
• Legal basis
• Content and format
• EUDRACT
• IMPD quality guideline
• Procedures, timelines, submission to regulatory authorities and ethic committees
• Voluntary harmonisation Procedure
• Substantial amendments
• Annual Safety Report
• End of Trial Notification
• First in man trials
Paediatrics – Authority Perspective
• Legal basis
• PDCO
• PIP, waiver, PUMA
Paediatrics – Industry Perspective
• Case story – how to handle the timing, requirements and patient Enrollment
Post Approval Activities
• Types of applications
• Content and formats
• Variations 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.
If you need hotel accommodation, we recommend Hotel Twentyseven where you will get a discounted price, but you are of course welcome to choose any other hotel that you might prefer, but the shuttle bus will go from Hotel Twentyseven to Medicademy in the morning and from Medicademy to Hotel Twentyseven in the afternoon. There are no hotels very close to the Medicademy facilities which is why we have chosen this hotel, very centrally located, situated in downtown Copenhagen and close to the central train station of Copenhagen (Københavns Hovedbanegård), to where the airport train goes. We have fixed prices at this hotel, which means that you are guaranteed to get the prices below. However, if the prices at some days/periods are lowered – you will of course get the lower price! Do always check the price of the day you stay there! Hotel Twentyseven
Hotel Twentyseven is located in the heart of Copenhagen, close to the Town Hall Square, the Tivoli Gardens, and Copenhagen Central Station, and airport trains, S-trains, regional trains, and busses leave from the station regularly. Hotel Twentyseven has a special atmosphere based on unique experiences, living design, seductive comfort, hospitality, and an uncomplicated life. All the 200 rooms in the hotel have been designed in the well-known Scandinavian design tradition by leading Danish designers & architects. www.hotel27.dk Fixed prices – breakfast included: Small single room - DKK 930 (approx. EUR 125), Double room for 1 person – DKK 1,080 (approx. EUR 145) Shuttle Bus - Included in the Course Fee!
Medicademy arrange transportation by bus every day from Hotel Alexandra in the morning to Medicademy and back again in the evening from Medicademy to Hotel Alexandra – included in the course fee!
The networking dinner takes place at Hotel Alexandra on the first night of the module - September 5, 2012! |
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Plads til diskussion – rigtig godt
Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer
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Tina Jensen
Tina Jensen is Program Director, Medicademy Regulatory Affairs and responsible for Introduction to Drug Registration.
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Lif Education, Diploma in Basic Pharmaceutical Medicine, Clinical Research, Drug Development, Medicademy Pharmacovigilance, Medicademy Regulatory Affairs, RA, PV, Pharmacovigilance, Regulatory Affairs
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