Medicademy Regulatory Affairs 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.
9 - 11 May 2012
Medicademy Regulatory Affairs Module 2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation
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.
12 - 14 September 2011
Medicademy Regulatory Affairs 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. The course will go into detail on how to interact with the various Centers at the FDA specific for Drugs (CDER) and Biologicals (CBER) 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.
2 - 4 November 2011
Medicademy Regulatory Affairs Module 5: Regulatory Strategic Considerations during Global Drug Development
The pharmaceutical industries as well as small start up biotechnology companies are under heavy pressure to develop new and effective drugs in order to maintain the financial expectations. In order to meet the objective which is a faster and more efficient drug development, the regulatory affairs expert has to play a more crucial role in the entire development process.
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. We have a number of international experienced speakers who will take the participants through the important key issues such as:
*Regulatory Affairs involvement in product development
*Regulatory Strategies
*Consultation with Authorities throughout development
*Regulatory Intelligence
*The development of a target label
*Regulatory planning in the submission step
*ntellectual property rights - Data exclusivity
*Pricing and reimbursement negotiations
At this module you will really get behind the regulatory decisions and strategies. Everyone working within the Regulatory Affairs Area knows how important and how much more effective you will be able to work if you have an in-depth understanding and knowledge of how and why the regulatory decisions are taken and the strategies made.
19 - 20 January 2011
Medicademy Regulatory Affairs Module 6, Quality - Drug Substance and Drug Product
To provide students with a comprehensive overview of the quality-related 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 substances and development of drug products to global quality trends, will be presented by international lecturers with extensive experience and expertise within chemical, pharmaceutical, and analytical development.
By the end of this module, the student should be able to:
- understand the basic principles of how to design, develop, and document drug substances and drug products, i.e. to understand how data are generated, and how the work is regulated by guidelines and standards
- analyse and evaluate development processes, reports, specifications, methods, and data - all seen from a regulatory point of view in order to ensure coherency and transparency of the quality dossier and other regulatory documentation
November 30 - December 2, 2011
Medicademy Regulatory Affairs Module 7, Non-clinical Development and Documentation
Module 7 will provide the students with a comprehensive overview of the requirements and critical issues of non-clinical studies and at the same time support clinical development, and provide them with an overview of how to build up a Common Technical Document of the non-clinical part of a
By the end of this module, the student should be able to:
- understand the purpose of each category of the non-clinical safety studies needed to support clinical development of pharmaceuticals, and understand how to build up the non-clinical part of a registration dossier
- analyse non-clinical requirements for specific types of medicine, clinical indications, and implications in relation to the composition and conduct of the non-clinical safety study programme
- use best practices when interacting with non-clinical specialists as well as with clinicians, CMC specialists, and the regulatory agencies in order to ensure that non-clinical safety information is generated, interpreted and communicated correctly to the benefit of the patient safety
The programme will focus on the development process:
• How do I select the right studies at the right time to meet 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?
February 22 - 24, 2012
Medicademy Regulatory Affairs Module 8, Clinical Development and Documentation
This module provides the students with an excellent opportunity to gain an overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of CTD (Modules 2 and 5). Clinical sections are especially important, when completing a marketing authorisation of a new product or product labelling and in meeting the needs of patients and the marketing of the product.
The module is targeted at regulatory employees, who wish to gain a better understanding of the interrelationships and complexities in clinical development and the current regulatory requirements for developing a new treatment. Further, it provides clinical development staff with the opportunity to gain a better understanding of the relation between regulatory and clinical strategies and of the documents that must be prepared prior to regulatory approval.
By the end of this module, the student should be able to:
- understand the regulatory requirements for obtaining a global marketing authorisation for a new treatment, including pharmacological testing, exploratory and confirmatory investigations, and commitments to be completed post-marketing
- create, analyse and evaluate a regulatory strategy plan for the clinical development of a new drug
- familiarise with the principles of clinical development from phase I to IV
- learn how to create competitive product information by optimising the clinical development plan and supporting the desired labelling
April 24 - 27, 2012
Medicademy Regulatory Affairs Module 9, Product Life Cycle Activities
This module is targeted at regulatory employees, who wish to improve their understanding of regulations and legal frameworks with an impact on Product Life Cycle Management, and of how to apply this understanding in regulatory Product Life Cycle Strategies. Students will gain knowledge and insight into regulatory requirements and opportunities in Life Cycle Management.
The module focuses on the current EU regulatory legislation and guidelines, and on the latest updates, e.g. the new EU variation legislation and guidelines, and paediatric regulation. The lectures will also provide a brief overview of differences to other regions.
By the end of this module, the student should be able to:
• Understand the basic principles of regulatory requirements for a pharmaceutical product in the post-approval phase, including how and when to apply for variations for CMC changes, labelling updates, SmPC updates, and renewals, as well as the regulations on paediatrics, risk management plans, referrals and generics
• Analyse and evaluate regulatory concerns and risks in life cycle management using relevant regulations and guidelines
• Advise and decide on the optimal regulatory strategies for life cycle management projects
• Use best practises in order to maintain regulatory compliance
In short, this module will provide students with a good base of knowledge of regulatory advice on the possibilities and consequences of different types of life cycle activities, and enable them to develop strategies, plan and perform activities related to the regulatory maintenance of a product in an everyday working environment.
June 6 - 8, 2012
Medicademy Regulatory Affairs 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. As process changes are inevitable during development of a biological/biotechnological product this course will provide the implications of changes in the production process and elaborate the concept of comparability.
By the end of this module, the student should be able to:
- understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product - including the critical parts of CMC/Quality sections of the filing dossier, and the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development and for approval of these types of medicinal products
- evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval, prepare regulatory CMC/Quality strategies, consider both FDA and EU aspects throughout the clinical development, and evaluate relevant regulations and guidelines for biopharmaceuticals
- use best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes, when preparing a CMC/Quality meeting with Authorities, and when structuring the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format
October 5 - 7, 2011
Medicademy Regulatory Affairs Module 11: Role and Responsibilities of a Regulatory Affairs Professional
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
April 19 - 20, 2011
Medicademy Regulatory Affairs Module 12: Medical Devices - Drug/Device Combinations
The module aims to provide students with a comprehensive knowledge of regulatory affairs within medical devices and drug/device combinations, and to enable students to:
• Offer regulatory strategic advice
• Compile adequate regulatory documentation
• Search for current and future regulations within the field
The module is targeted at regulatory employees from the medical device industry as well as from the drug industry. In particular, manufacturers/developers of medical devices used in combination with drugs (prefilled devices or devices, where the drug is ancillary to the device), or students with a special interest in this field will benefit from the module and gain a better understanding of the legal framework and its impact on such products.
By the end of this module, the student should be able to:
- understand the basic principles of medical device regulations, particularly in the EU, and to understand the basic requirements, when implementing a medicinal product - either as an ancillary drug substance to a medical device, or a drug product to be delivered by a medical device. Further, students will gain a better understanding of the consideration process behind various problems arising during the development of a combined product
- analyse and evaluate whether a combined product is regulated as a drug or as a medical device, and to be able to search for detailed information and provide proper input to projects regarding development of combined products. Further, students will be able to decide, whether a medical device used in combination with a drug should be registered in accordance with medical device legislation or drug legislation
- use best practices when evaluating whether a combined product is regulated as a medical device or as a medicinal product, and evaluate the documentation necessary to meet the regulatory requirements of a medical device
December 12 - 13, 2011
Medicademy Regulatory Affairs Module 13: The Regulatory Affairs Environment in Major Markets Outside ICH - Optimizing your regulatory strategy in the BRIC countries (Brazil, Russia, India and China)
Pharmaceutical, biotechnology, and generic companies are all under heavy pressure to expand their business on a global scale and to meet financial expectations. In terms of growth, the Emerging Markets, including the BRIC countries, indisputably lead the field.
When attempting to globalise a business and meet corporate commercial targets, regulatory affairs experts play a crucial role in initial market access, drug development processes, and in commercialisation of products or company portfolios.
Regulatory training usually offers information on the EU, the USA, and Japan, but rarely provides information on the wide range of markets covered under the expression “non-ICH”. Consequently, this module offers an overview of the regulatory requirements and challenges in the BRIC countries (Brazil, Russia, India and China) and attempts to support the optimisation of regulatory strategies on a global scale. The module will introduce students to guidelines and directives, and most importantly provide them with a basic knowledge of the strategic considerations behind global product development and life cycle management of a pharmaceutical product in the BRIC countries.
The course aims at providing Regulatory Affairs experts both the fundamentals and sophisticated tools for successful and effective operation in the non-ICH markets.
By the end of this module, the student should be able to:
- understand the challenges in working in a global environment and acquire knowledge of similarities and differences between the BRIC countries, know the importance of explicit agreements on requirements and timelines, and be familiar with the structure of national authorities
- analyse and evaluate the impact of national requirements towards their global Regulatory Strategy
- use best practices when creating a global regulatory strategy and achieve optimum balance between business needs, local requirements, and the overall strategic plan of a company
November 9 - 10, 2011
Medicademy Regulatory Affairs Module 14: Veterinary Regulatory Affairs in the EU
The module aims to provide students with a comprehensive overview of the veterinary regulatory affairs environment in Europe.
It is targeted at regulatory employees from the veterinary and human industries as well as employees in the pharmaceutical industry, who may find it relevant. Any employee with a special interest in the veterinary regulatory environment in Europe will gain a better understanding of the pharmaceutical law frame, and the requirements and challenges within this particular field.
By the end of this module, the student should be able to:
- understand the basic principles of regulatory requirements for veterinary medicinal products in EU, including the pre-approval, approval, and post-approval phase.
- advise and decide on the optimal regulatory strategies for veterinary products
- analyse and evaluate veterinary regulatory requirements using relevant regulations and guidelines
October 25 - 27, 2011