|
Medicademy Module R11: Roles and Responsibilities of a Regulatory Affairs Professional
|
|
 |
Registration deadline:
30 August 2012 Exam:Date of examination: October 29, 2012 You can tak the exam in your own country! Medicademy arrange examinations at Embassies, Universities etc. all over the world. Information about examination form etc. will follow. Remember to register for the exam separately! |
|
Register:
|
|
Startdate:
27 September 2012 - 28 September 2012 Purpose:
The module is intense and very interactive, and will provide all Regulatory Affairs Professionals with the opportunity to clarify, identify, and discuss his or her role and responsibilities as well as the role and responsibilities of a regulatory affairs department.
Through presentations, discussion, sharing of experience and workshops the participant will achieve a better understanding of how to combine their professional skills in order to obtain a larger impact on and influence within the organisation and business partners.
Students are required to prepare a presentation prior to attending the course, and this will enable them to understand their own role within regulatory affairs and to implement a good regulatory practice within their company.
By the end of this module, the student should be able to:
• Understand the role and responsibilities of a regulatory affairs professional, the basic principles of Good Regulatory Practice, the internal interaction of a regulatory affairs department with other departments, and externally, the standard operational procedures in a regulatory affairs department in order to comply with rules and regulations in the pharmaceutical industry
• Analyse the role and responsibilities of a regulatory affairs professional by means of presentations, discussions, and workshops, and by sharing experiences in order to fully understand how to combine professional skills and in that way obtain a larger impact on and influence within organisations and business partners
• Use best practices in day-to-day work and operate in a highly dynamic and constantly changing environment Content:
• The History and Role of Regulatory Affairs • Roles and Responsibilities of a Regulatory Affairs Professional • What is Good Regulatory Practice (GRP)? • How to Work with Good Regulatory Practices • How to Implement Good Regulatory Practice in the Students’ own Current Positions • The Diversity in Roles and Responsibilities within Regulatory Affairs in a Head Quarter, an Affiliate and a Small Biotech Company • What Skills are required for Regulatory Affairs Professionals? • Idea Generation in an Interactive Workshop • Cooperation, Communication and Skills
Course Leaders:
MSc Pharm, MSc Human Biology, Director, Regulatory Operations and Information, International Regulatory Affairs, Nycomed Group, Denmark Marianne Toft
Senior Regulatory Affairs Manager, AstraZeneca, Nordic, Denmark Helen Maria Shennan
Lecturers in 2011 - we expect to be able to present the same lecturers in 2012: Ma, Ph.D., Vice President, Regulatory Affairs & Drug Safety, NPS Pharmaceuticals, USA Sandra CottrellEli Lilly and Company Limited, UK Athanasios Konstantakopoulos
Alt4Kreativ, Denmark Finn Kollerup Actavis A/S, Denmark Inge Abildgaard
Azena, Denmark Hanne Christine Holmbom MSc Pharm, MSc Human Biology, Director, Regulatory Operations and Information, International Regulatory Affairs, Nycomed Group, Denmark Marianne Toft
Senior Regulatory Affairs Manager, AstraZeneca, Nordic, Denmark Helen Maria Shennan 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 |
 |
Plads til diskussion – rigtig godt
Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer
|
|
|
|
|
Tina Jensen
Tina Jensen is Program Director, Medicademy Regulatory Affairs and responsible for Introduction to Drug Registration.
|
|
|
Lif Education, Diploma in Basic Pharmaceutical Medicine, Clinical Research, Drug Development, Medicademy Pharmacovigilance, Medicademy Regulatory Affairs, RA, PV, Pharmacovigilance, Regulatory Affairs
|
|
|