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Organisation Description

PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We have a network of expert trainers who have a minimum of 10 years’ industry experience to meet your training requirements and all our courses are CPD certified. Our vision is to enhance key skills and competencies to drive continuous innovation and accelerate drug development. When you invest in a PTI course we want you to feel secure, inspired and ready to take on new challenges.

CPD Courses and Workshops Available

  • Filing Variations

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2 day course will teach you how to optimise your procedures for faster; streamlined and compliant submissions. The course is packed with exercises and case studies to meet your regulatory goals and tackle your everyday challenges.

  • Fundamentals of EU Regulatory Affairs

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. After three days you will have a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators. Through interactive exercises you will gain a practical insight into the European legal & regulatory environment; the registration procedures that are available; and the structure of the registration dossier. The course will adopt a practical approach that will enable you to apply what you have learned to your daily work.

  • Fundamentals of EU Regulatory Affairs Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. Over 4 weeks and 8 modules you will gain a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators. This course will give you a practical insight into the European regulatory environment throughout the whole product life cycle including: non-clinical and clinical studies; the various submission procedures; labelling and packaging; post-MAA obligations and activities and more.

  • Gaining Marketing Authorisations In CIS For Pharmaceuticals And Biotech

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2-day course will provide you with the latest updates on the regulatory processes for gaining marketing authorisation in CIS countries including registration procedures; timelines and fees plus key considerations for labelling requirements; regulatory maintenance and pharmacovigilance. Using a combination of theory and practical case studies; the course will allow delegates to develop the knowledge needed to successfully navigate the pharmaceutical market in Russia and other key CIS countries.

  • Genotoxic Impurities - Strategies For Identification And Control

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels; it is more important than ever for drug manufacturers to employ effective strategies for identifying; analysing and controlling GIs in their products. Using a combination of theory and practical case studies; the course will allow delegates to develop the knowledge needed to overcome everyday problems and enhance performance; ensuring you are employing the most appropriate analytical strategies for your products. This course is approved by the Royal Society of Chemistry; and is also available for studying online.

  • Genotoxic Impurities - Strategies For Identification And Control Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels; it is more important than ever for drug manufacturers to employ effective strategies for identifying; analysing and controlling GIs in their products. Led by Andrew Teasdale; this 4 week course will provide you with the latest updates on regulatory expectations; clarifying any grey areas to outline your responsibilities as the manufacturer. It will also advise on crucial aspects of risk assessments and safety testing. This course is approved by the Royal Society of Chemistry; and is also available as a face-to-face training course.

  • HPLC Method Development And Validation

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Over two days; this course will offer delegates the opportunity to examine the core aspects of HPLC theory and method development; including troubleshooting. Over the course of an optional third day; delegates will examine quantitation and method validation. Delegates may choose to attend either the first 2 or all 3 days. The course is also available as online course.

  • Introduction to HPLC; HPLC Troubleshooting and Method Development Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    HPLC is a potent analytical tool; allowing for the separation; identification and quantification of drug substances. It also presents many challenges; from basic underlying concepts; to troubleshooting problems; to optimising the resolution. This new course allows students to focus on: Introduction to HPLC; HPLC troubleshooting; HPLC method development. This course offers learners a choice of 3 topics; each containing 3 hour-long modules. Students may choose any one; two; or all three; depending on how advanced or basic their understanding of HPLC. The course is also available as face-to-face training.

  • Introduction To Pharmacokinetics For The Non-Specialist

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Pharmacokinetics (PK) and pharmacodynamics (PD) play a key role in drug development; and a good understanding of the implications of PK/PD data is crucial when designing clinical trials or preparing a drug submission dossier. This course assumes no prior PK knowledge; and aims to give a broad understanding of this fascinating subject; using multiple case studies and relevant examples. Over two days; you will learn what pharmacokinetics involves; what data is collected and how and its impact on the drug development process.

  • Introduction To Toxicology For The Non-Specialist

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    As many late stage failures and drug recalls result from unexpected toxicity in humans; a wider understanding of this field can help identify these problems earlier in development. Toxicology is a huge discipline; daunting if you need to communicate effectively with your toxicologists. This hands-on training course will give you everything you need to know to get a grip of this fascinating subject and increase your confidence when interacting with specialists.

  • Mastering Regulatory And Development Strategies For Generics

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. This course will allow the participants to gain a strategic insight into key requirements for developing generics from a global perspective and an overview of the generics market; current trends and practices; and future strategies for regulatory compliance.

  • Practical Development Of A Veterinary Pharmaceutical (Eu)

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This practical 2-day course has been designed to give you a comprehensive overview of the requirements that need to be met when developing a new veterinary pharmaceutical product. Over two days this course will explore all aspects of veterinary medicine product development with handy hints and tips to meet the quality; safety and efficacy requirements from development through to the registration of your new product in the EU.

  • Practical Solutions For Establishing In-Vitro In-Vivo Correlation

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    IVIVC is a critical tool described in many guidelines and its usage in development is recommended to reduce the risk of in-vivo testing. This 2-day practical training course; led by Jean-Michel Cardot; Auvergne University; will provide you with an interactive environment to address the many implementation issues of IVIVC. The course is packed with exercises and case studies to meet your goals and tackle your everyday challenges. This course is also available for studying online.

  • Practical Solutions For Establishing In-Vitro In-Vivo Correlation Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    In-vitro in-vivo correlation is a critical tool described in many guidelines and its usage in development is recommended to reduce the risk of in-vivo testing. Led by Jean-Michel Cardot; of Auvergne University; this 8-module course will allow you to consider the many implementation issues of IVIVC. Packed with examples and explanations; the course will build towards a comprehensive understanding of IVIVC; its limitations; data requirements and more. This course is also available as face-to-face training.

  • Project Management For Regulatory Affairs Professionals

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Recognized as a key criterion for success in many industries; effective project management may also be deployed to great effect within regulatory affairs. This course will provide you with an understanding of how project management principles and tools can be applied; allowing you to proactively plan for evolving timelines and requirements; engage stakeholders and combat resistance to change; streamline documentation requirements and more. You will learn using a combination of trainer-led presentations and group discussions to consolidate what you have learned.

  • Regulatory Affairs For Clinical Trials

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2-day practical course will take delegates through the essential regulatory requirements for clinical research in Europe and will also include key US requirements which impact on trials in Europe. The course will also focus on the new Clinical Trial Regulation providing you with practical advice for implementing it. The course will also highlight the major differences between the Regulation and the current Directive.

  • Regulatory Affairs For Veterinary Medicines

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2-day practical course is designed for the regulatory professional to give a complete guide to the regulatory guidelines surrounding the authorisation of veterinary medicinal products in the EU. As the market for veterinary medicinal products grows; so too do the requirements for regulatory compliance. The course will provide you with the fundamental regulatory knowledge to unpick the complexity of the system and apply your knowledge to achieve fast product approval and effective product maintenance.

  • Regulatory Affairs In Latin America

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    With so many varying requirements across Latin America; navigating the regulations can be difficult and time consuming. This 2-day course will take you through the process of compiling the dossier; clinical trials; commercial landscape and pharmacovigilance in each country so you have the skills and confidence to operate in the region. Countries discussed: Brazil | Mexico | Argentina | Columbia | Venezuela | Chile | Peru | Ecuador | Paraguay.

  • Regulatory Affairs Strategy

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data; inaccurate indications being submitted; and inappropriate procedures being used. The financial consequences are potentially devastating. This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.

  • Regulatory Information Management & IDMP Training

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Over two days you will learn the key aspects of RIM and the new IDMP standard such as training and user compliance; outsourcing and data/content management. Once completed you will have the necessary skills to plan; prepare and implement a strategy ready to meet IDMP deadlines.

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