CAREER DEVELOPMENT FOR EXPERIENCED REGULATORY PROFESSIONALS

Transcription

1 CAREER DEVELOPMENT FOR EXPERIENCED REGULATORY PROFESSIONALS How TOPRA can support you as you drive your regulatory career forward

2 ABOUT TOPRA TOPRA (The Organisation for Professionals in Regulatory Affairs) is the professional association exclusively for individuals engaged in regulatory affairs and regulatory science in healthcare. OUR MISSION Our aim is to promote the profession and encourage excellence in its practice. HOW WE DO THIS The global TOPRA community includes members from industry, agency and support companies, in pharmaceuticals, medical devices and veterinary medicine, who can progress through the membership grades as their career develops. TOPRA members subscribe to a Statement of Values which provides an ethical framework for regulatory professionals. TOPRA supports its members throughout their regulatory careers by the provision of a structured professional development programme, formal educational qualifications (including the MSc and PhD programmes), information resources including a peer reviewed journal and the opportunity for informal networking and independent debate.

3 CONTENTS PROGRESSION PATHWAYS 2 THE MASTERCLASS PROGRAMME 4 GET THE BIGGER PICTURE 7 DEVELOP STRATEGIC LEADERSHIP 9 INCREASE YOUR OPERATIONAL EXPERTISE 12 TOPRA MSc IN REGULATORY AFFAIRS 16 Enabling and promoting excellence in the healthcare regulatory profession 1

4 PROGRESSION PATHWAYS As regulatory professionals we are fortunate to have a wide variety of career choices. In order to be successful, regulatory professionals must keep up to date and continually refine their skills and knowledge. TOPRA supports members in doing this by providing a continuing professional development (CPD) programme and encouraging all members to identify their learning needs and how these might be addressed; then to meet these needs by whatever means is most suitable (eg reading, mentoring, courses) and evaluate the effectiveness of that learning and record it as part of their CPD record. TOPRA offers training courses, conferences and networking opportunities that help to provide you with the technical information and skills development you need at all stages of your career. Although every individual career pathway is different, we have identified five key stages that can be applied to any regulatory career. KEY STAGES IN YOUR REGULATORY CAREER 1. EXPLORING Those wanting to take their first steps in regulatory affairs Those in other disciplines who need an overview Up to 6 months experience Exploring: entrants to the profession who are investigating regulatory affairs as a career are at the exploring stage our Basics courses are ideal for people starting their careers or considering a move from a related sector, eg medical writing. Establishing: professionals who have decided on a regulatory career and are building a firm foundation in the fundamentals are at this stage. Our Foundation courses (such as the Introductory Courses) are ideal for this stage. Consolidating: the stage at which committed regulatory professionals typically those having about 2 5 years experience are building expertise in a specific range of areas or projects. Our CRED programmes are tailored for their level of experience. 2. ESTABLISHING Those who have recently joined the profession Those whose regulatory experience is outside the EU 6 months 2 years experience 2

5 Driving: supporting those who have worked in the field for a while and want to make their mark in the regulatory profession. They may be taking on management responsibility, running a business or becoming an in-house expert or even moving into a related area like HTA/PV. Our Masterclasses and Horizons courses and conferences, are developed to meet their needs. Influencing: these regulatory professionals have reached the level of senior directors or vice presidents often with Fellowship of TOPRA too. They have strategic roles and play on the wider stage, maybe influencing new legislation through trade bodies and other external organisations. Our Roundtables and Fellows Dinners, as well as the Annual Symposia, will give them the opportunity to look at future developments and debate the issues. All TOPRA training and educational courses and conferences are linked with these stages, making it even simpler to plan your own personal development programme and to source training for your regulatory team. Go to topra.org/careers for more information. 3. CONSOLIDATING Experienced professionals committed to developing their regulatory and management competencies 2 5 years experience 4. DRIVING Those at a senior level taking on additional responsibilities or looking to diversify their skills 5+ years experience 5. INFLUENCING Discussion, debate, and networking opportunities for senior professionals 8+ years experience This booklet is targeted at experienced professionals who are driving their career forward. Our programme of Masterclasses is a perfect opportunity for you to study and keep up-to-date on the crucial aspects of regulatory affairs. 3

6 THE MASTERCLASS PROGRAMME INTRODUCTION TOPRA has more than 25 years experience in delivering a structured, continuing development programme of courses, meetings and seminars to meet the needs of regulatory professionals at all stages in their careers. Our residential Masterclass courses are designed to meet the educational and vocational needs of experienced regulatory professionals in the pharmaceutical and allied industries. STRUCTURE OF EACH MASTERCLASS Each pharmaceutical Masterclass lasts 2.5 days and is built around lectures, case studies and discussion groups. Lecturers are drawn from the industry, regulatory authorities and academia. Around five pharmaceutical Masterclasses are held each year. Emphasis in most of the courses is given to discussion of European regulatory requirements and to practical problems involved in meeting them. Where appropriate, comparisons are made with the regulatory requirements of other major markets. A total of 12 continuing professional development Masterclasses are on offer providing the opportunity for experienced regulatory professionals to gain valuable in-depth knowledge and updates. A summary of the Masterclass programme, grouped into courses that provide an overview, those that focus on regulatory strategy and those that concentrate on developing operational skills and expertise, is given below. OVERVIEWS The US Regulatory Environment Medical Device Regulatory Affairs IN-DEPTH KNOWLEDGE OF REGULATORY STRATEGY Strategic Planning in Regulatory Affairs Regulatory Strategy for a New Active Substance: Nonclinical Development Regulatory Strategy for a New Active Substance: Global Clinical Development Regulatory Strategy: The Market Place Regulatory Strategy for Established Active Substances 4

7 OPERATIONAL SKILLS AND EXPERTISE Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy Regulatory Control of Clinical Operations Data Requirements for Abridged Applications and Specialised Products Registration of Biological, Biotechnology and Advanced Therapy Products Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation MASTERCLASSES IN MEDICAL TECHNOLOGY REGULATORY AFFAIR Medical device regulatory professionals have access to their own specialised Masterclasses to deepen their knowledge and competencies in this highly specialised area of regulatory affairs. You can take 3-day residential Masterclasses on any or all of the following topics: Principles of European Medical Technology Regulatory Affairs Design, Development and Testing of Medical Technology Clinical Evaluation of Medical Technology Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management Regulation of Drug-Device Combinations and Other Medical Technology Products US Regulation of Medical Technology Regulatory Strategy in the Market Place The Masterclasses are part of a collaboration between Cranfield Health and TOPRA. They comprise part of the TOPRA MSc in Medical Technology Regulatory Affairs go to or enquiries.health@cranfield.ac.uk. 5

8 6 This programme was a valuable experience for me and I have already recommended the course to some of my colleagues, as I believe it can be very helpful to their careers

9 GET THE BIGGER PICTURE THE US REGULATORY ENVIRONMENT You will have the opportunity to explore and appreciate the regulatory issues likely to arise during drug development in order to be able to provide effective advice on the regulatory affairs activities involved with drug development in the US. Examine the legal basis of pharmaceutical regulations in the US and how the FDA operates within the legal framework Differentiate the format and content of IND, NDA, BLA, ANDA and SNDA submissions, and examine the practical issues associated with these applications Analyse FDA approaches to specific product types such as OTC products and orphan drugs Assess the impact of US regulatory affairs on the global development and regulatory strategy for pharmaceuticals. NEXT COURSE: April 2016 complementary Masterclasses on Global Regulatory Strategy; Global Clinical Development and Regulatory Strategies for Biotechnology Products. MEDICAL DEVICE REGULATORY AFFAIRS This is an opportunity for pharmaceutical regulatory professionals to gain a good understanding of the regulatory control of medical devices in the EU. You will be able to advise on the application of the medical device directives and how to achieve CE marking for products. Distinguish the routes to Conformity Assessment in the EU Assess the role of the Competent Authorities and the Notified Bodies Define the requirements of post-market surveillance and vigilance, and the role that risk management plays throughout the lifecycle of a device Compare how medical devices are regulated in other markets and examine related international activities such as the Global Harmonisation Task Force Interpret the requirements of clinical evaluation, learn how to initiate a clinical study and understand the ever-increasing impact of Health Technology Assessment. NEXT COURSE: November/December 2016 You may be interested in complementary Masterclasses from the MSc Medical Technology Regulatory Affairs, see page 5. 7

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11 DEVELOP STRATEGIC LEADERSHIP STRATEGIC PLANNING IN REGULATORY AFFAIRS As you progress through your career, aspects of project management and strategic planning become more important. You will need to develop the ability to anticipate problems, analyse complex situations, and offer the optimal strategy in order to achieve marketing approvals worldwide in a timely manner. This Masterclass will help you to consider and appreciate strategic regulatory aspects of global regulatory affairs and provide effective advice on the commercial implications of regulatory affairs activities involved with approval and pricing negotiations. Determine the global regulatory strategies and development programmes required to achieve marketing authorisation approval in Europe, North America, Japan and beyond Assess and discuss the commercial implications of regulatory approval and pricing negotiations Analyse regulatory issues relating to in- and out-licensing of products Define the interactions between the company and regulatory agencies. NEXT COURSE: December 2014 complementary Masterclasses on Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation; and Regulatory Strategies in the Marketplace. The greatest strength of the course is the wealth of experience provided by the speakers... The people involved are very experienced and enthusiastic about the profession 9

12 NONCLINICAL DEVELOPMENT: NEW ACTIVE SUBSTANCES This Masterclass will provide you with an understanding of the key requirements and submissions strategies associated with the nonclinical development process so that you can provide effective regulatory leadership throughout this phase. It will allow you to explore and understand nonclinical regulatory aspects for global drug development. It covers the regulatory issues likely to arise during nonclinical programmes. Describe the research processes used to identify and select new candidate compounds Analyse the types and designs of nonclinical safety studies required to successfully develop a new product Assess the regulatory acceptability of nonclinical development programmes and determine the format and content as well as submission strategy for such information Interpret pharmacokinetic principles and how these are applied to link the nonclinical and clinical components of pharmaceutical development. NEXT COURSE: 4 6 February 2015 complementary Masterclasses on Global Clinical Development; and Registration of Biotech and Advanced Therapy Products. GLOBAL CLINICAL DEVELOPMENT: NEW ACTIVE SUBSTANCES You will consider regulatory strategic aspects of global clinical research, as well as review the global regulatory issues likely to arise during multinational clinical trials. This Masterclass will also help you demonstrate effective regulatory leadership in your organisation throughout the clinical development and registration of a new medicine. Differentiate the types of clinical study design and identify the pros and cons of each within the context of global regulatory requirements Evaluate the medical, statistical, economic and operational principles underpinning the successful conduct of a clinical trial programme Identify the activities required to ensure that data suitable for a product registration are derived from the clinical studies programme Determine the strategic role of clinical study reports and summaries in obtaining an optimal product label Understand the regulatory authorities views of the clinical dossier. NEXT COURSE: 3 5 June 2015 complementary Masterclass on Regulatory Control of Clinical Operations. 10

13 REGULATORY STRATEGY IN THE MARKET PLACE Investigate the role of regulatory strategy in commercialising products and maintaining the brand throughout a product s lifecycle. You will explore the regulatory issues likely to arise during commercialisation so you can give effective advice. Recognise the needs of marketing colleagues in commercialising products and maintaining brand awareness through the development of new dosage forms, indications and switching of legal status Optimise the marketing life of a product by use of patents and supplementary protection certificates and demonstrate how regulatory professionals help maintain the edge that such protection might offer Evaluate the role of regulatory affairs in optimising regulatory strategy in a manner that is sympathetic to the needs of pricing and reimbursement committees, so that commercial advantages may be gained Illustrate the importance of the SmPC as a means of communication with prescribers and for patient information Define the responsibilities and requirements for keeping the licence current with respect to the reporting of adverse drug reactions. NEXT COURSE: November 2015 complementary Masterclasses on Strategic Planning; and Strategies for Established Active Substances. REGULATORY STRATEGY FOR ESTABLISHED ACTIVE SUBSTANCES Gain an understanding of the strategic issues to be addressed in relation to medicines containing established active substances, including line extensions, generics and OTC products. It is an opportunity to review the regulatory issues likely to arise for established active substances. Distinguish between the differing types of abridged applications possible in the EU and identify situations when the use of each of these is appropriate Design and evaluate strategies for submissions in EU markets for products containing established active substances Compare the routes to approval in the US for products containing established active substances, sufficient to provide regulatory leadership to colleagues in this market. NEXT COURSE: March/April 2016 complementary Masterclasses on Data Requirements and Specialised Products; Registration of Biotech and Advanced Therapy Products; and the US Regulatory Environment, which provides more detail on regulation of established active substances in the US. 11

14 INCREASE YOUR OPERATIONAL EXPERTISE NEW CHEMICAL ACTIVE SUBSTANCES: CHEMISTRY AND PHARMACY The focus of this Masterclass is to explore and understand the regulatory issues likely to arise during chemistry and pharmacy data documentation requirements for drug development. You will develop a sound understanding of the chemistry and pharmacy development programme in order to provide effective advice on the suitability of the chemistry and pharmacy programmes from a regulatory perspective. Identify the drug substance requirements: nomenclature, description, synthesis, development chemistry, quality control during synthesis and stability Define the drug product requirements: formulation and pharmaceutical development, dissolution testing, bioequivalence of different dosage forms used in clinical trials, manufacture, GMP, process validation, specifications and routine tests, analytical method development, packaging and stability Recognise the importance of analytical validation Discriminate between the chemical and pharmaceutical aspects of clinical trial and marketing authorisation applications Define the formatting of the chemistry and pharmacy documentation as per the requirements of the Common Technical Document Understand the regulatory authorities views of the chemistry and pharmacy dossier. NEXT COURSE: April 2015 complementary Masterclasses on Regulatory Strategy for a New Active Substance; Data Requirements for Abridged Applications and Specialist Products; and the US Regulatory Environment, which covers specific requirements for New Drug Applications in the US. 12

15 REGULATORY CONTROL OF CLINICAL OPERATIONS Gain an understanding of the practical regulatory aspects of global clinical research, so you can provide effective advice on the regulatory issues likely to arise during clinical programmes. Understand the practical aspects of GCP and how it supports clinical research Identify the regulatory requirements for clinical research in major markets, understand the importance of the EU Clinical Trial Directive and how to prepare clinical trial applications and associated documentation Consider the complexities and requirements of pharmacovigilance in clinical research Understand the management of clinical trial supplies and the requirements of GMP, authorisation and importation of investigational medicinal products Understand clinical trial reporting, the management of the data, data auditing and the practicalities of GCP inspections. NEXT COURSE: September 2015 complementary Masterclass on Regulatory Strategy for Global Clinical Development. DATA REQUIREMENTS FOR ABRIDGED APPLICATIONS AND SPECIALISED PRODUCTS This Masterclass will help you understand the diversity of abridged applications, and the data requirements for a variety of new dosage forms and new indications as well as data requirements for certain specialised products. You will have the opportunity to explore and critically debate the regulatory issues likely to arise for abridged applications and specialised products in order to be able to provide effective advice. Identify the chemical/pharmaceutical, nonclinical and clinical data required for line extensions taking into account the interaction between the various parts of a dossier Define the requirements for bridging data in various situations Examine the data requirements for line extensions, generic applications and for specialised products Evaluate the data requirements for Supplemental Applications in the US. NEXT COURSE: June 2016 complementary Masterclass on Regulatory Strategy for Established Active Substances. 13

16 REGISTRATION OF BIOLOGICAL, BIOTECHNOLOGY AND ADVANCED THERAPY PRODUCTS This advanced course will help you get to grips with regulatory strategy for biological, biotechnology and advanced therapy products. It is an opportunity to study and understand the scientific principles underpinning development of biological/ biotechnology products and how their inherent complexities impact on regulation. Discern the differences between a biological and a chemical entity and recognise and interpret the complex nature of biological/biotechnology products Demonstrate a comprehensive understanding of the regulatory requirements and associated documentation with the licensing of biological, biotechnology and advanced therapy products Analyse the implications of change in production process on product and the concept of comparability Critically appraise and evaluate communications from regulatory bodies and research publications regarding biological, biotechnology and advanced therapy products. NEXT COURSE: February 2017 complementary Masterclasses on Global Regulatory Strategy; Nonclinical Development; New Active Substances and Regulatory Control of Clinical Operations. 14 OPTIMISING THE REGULATORY CONTRIBUTION TO PRODUCT DEVELOPMENT, MAINTENANCE AND COMMERCIALISATION You will explore the management issues likely to arise in running a successful regulatory department for product development, maintenance and commercialisation. Identify the skills you will need to optimise your department s contribution to this process. Collaboration with other key departments will be addressed, including an introduction to the influencing and negotiation skills needed for effective teamwork. Examine tools such as regulatory intelligence and IT that are available to help manage a department Categorise the key departments with which regulatory affairs needs to work cooperatively Establish how regulatory professionals can maximise their contribution to product development, maintenance and commercialisation by collaborating and negotiating appropriately with other departments Evaluate the necessity of project/ portfolio management and decision analysis. NEXT COURSE: September 2016 complementary Masterclass on Strategic Planning which includes the commercial implications of drug development.

17 I met many interesting people with whom I am still in contact. With some of them we even developed a professional relationship which proved very valuable for our business 15

18 ADVANCE YOUR PROFESSIONAL CAREER WITH A QUALIFICATION THE TOPRA MSc IN REGULATORY AFFAIRS All Masterclasses can be taken as part of the TOPRA part-time MSc in Regulatory Affairs. The MSc in Regulatory Affairs, offered by TOPRA and validated by the University of Hertfordshire, provides a unique opportunity to study aspects of regulatory affairs at an advanced level. The MSc course is designed for regulatory affairs professionals working in the pharmaceutical industry. To operate successfully, regulatory professionals require a thorough understanding of regulatory affairs in all its aspects and the ability to apply the knowledge in a strategic way. The programme of individual modules was developed to provide the wide knowledge base necessary to fulfil the regulatory affairs function. The syllabus encompasses major aspects of pharmaceutical legislation, scientific principles and commercial practice underpinning the role of regulatory affairs. The course was established in 1989, and it is designed for professionals working in regulatory affairs who have already gained first-hand experience of handling regulatory issues. Such experience may be in one area of regulatory affairs that could be developed and broadened by studying for the MSc. Alternatively, your experience may cover a wide regulatory area but would benefit from the in-depth considerations of the topics covered in the course. Studying for the MSc can therefore benefit regulatory professionals at a relatively early stage in their regulatory career, or more experienced people who have perhaps worked in related industrial functions before specialising in regulatory affairs. To obtain the MSc you must take eight modules and satisfy the other requirements stated in the schedule of assessment, including the completion of a research-based dissertation in five years. You can enrol for the MSc at any module or Masterclass course. TOPRA takes full responsibility for the operation and management of the course, which is fully validated by the University of Hertfordshire. If you are interested in taking the MSc in Regulatory Affairs mscadmin@topra.org 16

19 7FHH1097 Overview of EU Regulatory Affairs Spring/Autumn annually 7FHH December 2014 Strategic Planning in Regulatory Affairs 7FHH February 2015 Regulatory Strategy for a New Active Substance: Preclinical Development 7FHH April 2015 Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy 7FHH June 2015 Regulatory Strategy for a New Active Substance: Global Clinical Development 7FHH1102 September 2015 Regulatory Control of Clinical Operations 7FHH1103 November 2015 Regulatory Strategy: The Market Place 7FHH1104 March/April 2016 Regulatory Strategy for Established Active Substances 7FHH1105 June 2016 Data Requirements for Abridged Applications and Specialised Products 7FHH1106 February 2017 Registration of Biological,Biotechnology and Advanced Therapy Products 7FHH1107 September 2016 Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation 7FHH1108 April 2016 The US Regulatory Environment 7FHH1109 November/December 2016 Medical Device Regulatory Affairs 7FHH1110 Dissertation The 13 modules available for students to study as part of the MSc go to for the latest information (dates correct as of October 2014). 17

20 Bellerive House, 3 Muirfield Crescent, London E14 9SZ T: +44 (0) F: +44 (0) E: topra@topra.org W: TOPRA The Organisation for Professionals in Regulatory Affairs Ltd. Registered in England company number A company limited by guarantee