Module 1: The Pharmaceutical Law Frames in the EU
The purpose of Module 1 is to give the participants an understanding of the background of the EU legal system and the collaboration with other institutions.
May 6 – 7, 2010

Module 2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation
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.
September 1 – 3, 2010

Module 3: The Regulatory Affairs Environment in the USA
The aim of this module is to ensure an understanding of how to best develop and gain approval for a new drug or biological in the USA with emphasis on the requirements for development and maintenance of new drugs. During drug development the sponsor should interact with the Food and Drug Administration (FDA) on a regular basis to gain agreement on the best program of studies to provide the data required by the agency to demonstrate the efficacy and relative safety of the drug for the proposed indication. In addition the sponsor must demonstrate that the drug meets the quality standards required for approval.  There are also various programs available that may be used to speed drug development and regulatory approval if requested by the sponsor and agreed to by the agency.
October 6 – 8, 2010

Module 4: The Regulatory Affairs Environment in Japan
The aim of this module is to clarify the needs, expectations and regulatory requirements in Japan and be able to identify key elements in a JIND and a JNDA. The participants should understand how to work within the Regulatory Affairs environment in Japan from a substance in early research all the way to post-approval requirements inclusive.
TBD

Module 5: Regulatory Strategic Considerations during Global Drug Development
Regulatory courses normally focus on the text in laws, guidelines and directives, but you learn little about your role as a regulatory expert in project teams. Therefore, in module 5 we will not focus on guidelines but go beyond them and provide the participants with knowledge of the background and thinking behind the key factors of global regulatory strategies.
November 9 – 10, 2010

Module 6: Quality – Drug Substance and Drug Product
The purpose of this module is to provide a comprehensive overview of the requirements and critical issues of the quality part of the dossier with interfaces to product development and post-approval maintenance.
The various subjects ranging from chemical synthesis of active drug substances and development of Drug Product to gloal quality trends are represented by international speakers with significant experience and expertise in drug development.
November 3 – 5, 2010

Module 7: Non-clinical Development and Documentation
The purpose of this module is to provide the participants with a comprehensive overview of the requirements and critical issues of non-clinical studies to support clinical development and how to build up the Common Technical Document of the non-clinical part of the registration dossier (e.g. CTD module 2 and 4). The programme concentrates on the development process:
How do I select the right studies at the right time to fulfil the company’s needs and the regulatory requirements?
How do I evaluate the results?
What is the predictive value of the results?
What should I know about CMC and clinical development?
December 1 – 3, 2010

Module 8: Clinical Development and Documentation
The program concentrates on the clinical development process and with a focus on EU primarily:
How do we know that we are doing the right studies to satisfactorily demonstrate the efficacy and safety of the new treatment?
Will we get product labelling that meets marketing’s needs?
Do we have enough patients in our development program?
Can we speed up the development process and the regulatory review?
Can the drug development plans support global marketing also through life cycle management?
How is clinical risk assessment handled during development and the pharmacovigilance process ?
February 1 – 4, 2011

Module 9: Product Life Cycle Activities
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. 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.
April 19 – 21, 2010

Module 10: Biopharmaceuticals - Quality Development and Documentation 
The aim of this module is to give Regulatory Affair employees knowledge about the scientific background of biologics and biotechnological products and the regulatory requirements to fulfil, in order to obtain approval of these types of medicinal products.
Attendees of the course will get an understanding of the quality issues specific to biopharmaceuticals, for example; the generation of a recombinant microorganism, the expression of the product from the microorganisms and its purification, and the regulatory expectations for characterization of a biopharmaceutical product and to release/stability specifications set for these types of products.
November 17 – 19, 2010

Module 11: Role and Responsibilities of a Regulatory Affairs Professional
This 2 day intensive and very interactive module gives the Regulatory Affairs Professional an opportunity to clarify, identify and discuss their own role and responsibilities as well as the role and responsibilities of the regulatory affairs department within the company. 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.
TBD

Module 12: Medical Devices – Drug/Device Combinations
The aim of the module is for the participants to obtain the necessary level of knowledge within the Regulatory Affairs for drugs and devices in combinations enabling the participants to:
Provide regulatory strategic advices.
Compile adequate regulatory documentation.
Search for current and future regulations in the area.
This module is aimed at regulatory employees both from the medical device industry and drug industry. If you are a manufacturer/developer of medical devices used in combination with drugs (prefilled devices or devices where the drug is ancillary to the device), or if you just are interested in obtaining knowledge about the area, this module will give you a better understanding of the legal framework having an impact on such products.
June 7 – 8, 2010

Module 13: The Regulatory Environment in Major Markets outside ICH - How you can optimise your regulatory strategy dealing with the BRIC Countries (Brazil, Russia, India and China)? 
The majority of Regulatory Training offers information respective the European Union, the US and Japan but information about the wide range of markets covered under the expression “non-ICH” are rarely provided. As representative markets for the non ICH region this module offers an overview of the regulatory requirements and challenges in the BRIC countries (Brazil, Russia, India and China) and thereby supports the optimization of the Regulatory strategy on a global level. During this module guidelines and directives are introduced, but, most importantly, beyond that we provide the participants with knowledge about the strategic considerations that are essential for the global product development and the entire life cycle management of a pharmaceutical product in the BRIC countries.
May 10 – 12, 2010