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.

Medicademy’s, Module 3, The Regulatory Affairs Environment in the USA, is an excellent opportunity for anyone working in drug development with the USA in their daily work – not only Regulatory Affairs Professionals – to obtain an in-depth and up to date knowledge of 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, biological or device in the USA with emphasis on the requirements for 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 or device 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. The course will go into detail on how to interact with the various Centers at the FDA specific for Drugs (CDER), Biologicals (CBER) and Devices (CDRH) from early non-clinical and clinical research to post-approval obligations. The course will provide the participants with detailed knowledge of US specific documentation requirements and where relevant compare and contrast these to EU and ICH guidelines and requirements.

The content of this course is also designed to understand all the components of INDs, NDAs, BLAs, ANDAs and PMAs and 510ks. The content of these submissions that are required by Federal Regulations, FDA guidelines and ICH guidelines will be presented and discussed in detail.

Participants will be supplied with the most relevant and updated information specific to these submissions. For the IND, the individual items of the IND will be analyzed in conjunction with their importance, level of detail, and necessity so that sufficient information will be provided and the IND clinical studies may begin without delay, 

The items of the NDA, BLA, ANDA and PMAs and 510ks will also be detailed and discussion for each item will reflect on how to best present the pre-clinical, clinical and CMC data for successful approvals of New Drug, Supplemental and Abbreviated Applications.

- in Europe!                                                                                                     

You will find a very strong programme drawn up by both Japanese and outside experts, which will give you both the inside and the outside perspective of how to work with the Japanese Regulatory Affairs. If your company is already involved in Japan or is thinking abot getting involved - you will not find a better offer of getting the necessary updated knowledge of the Regulatory Affairs Environment in Japan!

Regulatory courses normally focus on the text in laws, guidelines and directives, but you learn little about your role as 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 behind global regulatory strategies.

This module is aimed at regulatory employees who would like to get a better understanding of how to work with the non-clinical part, but also toxicologists could benefit from this module by getting a better understanding of whay they should deliver to the regulatory department.

The aim of Module 11 is to give the participants an understanding of their role and responsibilities in all aspects of a drug development process and product life cycle management, to understand the role of Regulatory Affairs in the organisation, to learn how the building of quality into daily activities can improve Regulatory Affairs performance and result in faster submissions and approvals, to understand the quality aspects’ influence on Regulatory Affairs, to understand the basic issues of Good Regulatory Practice (GRP) incl. policies, processes and standards, to understand what is expected of Regulatory Affairs Professionals as specialists, co-ordinators and trouble-shooters and to learn the value of communication and co-operation skills as a tool to improve Regulatory Affairs performance.

At Module 11 the participant will get an understanding of:

·          Their role and responsibilities in all aspects of a drug development process and product life cycle management

·          The role of Regulatory affairs in the organisation

·          How the building of quality into daily activities, can improve Regulatory Affairs Performance and result in faster submissions and approvals

·          The quality aspects’ influence of regulatory affairs

·          The basic issues of Good Regulatory Practice (GRP) including policies, processes and standards

·          An understanding of what is expected of Regulatory Affairs Professionals as specialists, co-ordinators and trouble-shooters

·          Learn the value of communication and co-operation skills as a tool to improve regulatory affairs performance