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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

  • Advanced European Regulatory Affairs

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    The regulatory affairs market has always been of a fluid nature due to the constant changes in European regulations. Regulatory adherence is imperative for obtaining and maintaining marketing authorisation. This 3-day course will examine the current European legislation and understand the consequences these have on a Regulatory Affairs Manager. It will also compare the regulatory requirements between Europe and the rest of the world. Once completed delegates should be fully up-to-date with the latest legislations and be equipped with the knowledge and confidence to instigate the optimisation of the in-house regulatory procedures.

  • Introductory Level CMC Analytical; Comparability & Stability Testing And Lab Practices For Biotech And Biosimilar Products

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This course will provide attendees with a concise but comprehensive overview of all relevant regulatory; technical and quality elements necessary to assure successful design; implementation and documentation of the required CMC analytical and stability studies for biotechnology products; including biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented; and strategies for preventing (or remediating) gaps will be presented. Attendees will be given a USB drive containing a complete set of all regulatory documents and industry white papers currently applicable to biotechnology product analytical CMC requirements that covers the entire product development lifecycle.

  • Advanced Level CMC Analytical; Comparability & Stability Testing And Lab Practices For Biotech And Biosimilar Products

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2-day course is designed to follow PTI’s introductory level course; but may also be taken as a stand-alone class for attendees with experience in aspects of biotechnology. Details will be presented on technical issues in designing and executing specific critical analytical studies. Practical examples will be provided as illustration for key studies and ample time will be allowed for discussion designs and outcomes. Finally; tips on the suitable generation of internal study reports and the presentation of data for regulatory dossiers will be given. All attendees will be given a USB drive containing over 200 current and draft global regulatory and quality guidance documents associated with the development and commercialisation of biotech and biosimilar products.

  • Analysing Bioassays And Immunoassays

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This two day course will cover basic statistical processes necessary for analysis of the data from bioassays; setting up meaningful system suitability acceptance criteria and designing validation plans. Important considerations will be examined such as choosing the appropriate non-linear or linear regression fit; calculating correct residual weights; computing practical limits of sensitivity and acceptable error; and measuring non-parallelism and potency. This course is also available for studying online.

  • Analysing Bioassays And Immunoassays Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This course will build on your understanding of bioassays and immunoassays; helping you to come to grips with assay development; troubleshooting; performance management and more. Over 10; detailed modules you will understand key techniques for validation design and implementation and how to align to regulatory standards. In addition; you will become familiar with biostatistics and key data analysis methods. This course is also available as a public training course.

  • Bioavailability & Bioequivalence

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Bioavailability (BA) is defined as the rate and extent to which the unchanged active substance is absorbed and becomes available in the systemic circulation. Understanding bioavailability is essential during drug development as it is one of the fundamental properties of drug formulation. Information on bioavailability is also used to determine bioequivalence (BE) when submitting a generic dossier. This 2-day course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis; statistical analysis and reporting. The course will also examine key aspects of biowaivers such as the regulatory hurdles; types of biowaivers; data needed and the risk associated with submitting a biowaiver.

  • Bioprocess And Analytical Method Development - Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Over 4 weeks and 7 modules; this course offers an accessible look at process and analytical method development for such products. Beginning with the fundamentals of bioprocessing analysis and characterisation; learners will progress through the production process from upstream to harvesting and purification to downstream and formulation. Other aspects such as use of analytical methods; viral safety and regulatory considerations will also be explored.

  • Bioprocess Characterisation; Qualification And Validation

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    The biotech industry has grown significantly with the majority of new novel medicines being biopharmaceuticals; such as monoclonal & polyclonal antibodies; recombinant DNA proteins and viral gene therapies. This course will provide delegates with a complete understanding of process development; characterisation; qualification; verification and validation to ensure efficient and compliant bioprocessing facilities. Quality by Design (QbD) is becoming increasingly important throughout industry; including in biopharmaceutical manufacturing. Over two days you will gain an introductory overview of QbD and understand how to utilise small-scale models; assess risk and be compliant with current EU regulations.

  • Biowaivers: Practical And Regulatory Approaches Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This course will help improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks; using case studies and practical guidance. By examining the requirements for BCS-based; Strength and IVIVC biowaivers; you will have the confidence and skills to implement a strategic approach for new product registrations.

  • Budget Management For Clinical Trials

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2-day course provides you with the necessary skills to formulate and implement a successful clinical trial budget. Through a combination of theory; case studies and practical discussion sessions; this course will help you understand the budgeting process; share best practice; facilitate cross-company collaboration; define fair market value and standardise the clinical grant process within your business.

  • Challenges In Drug/Device Combination Products

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Drug/device combination products present unique challenges. Under EU law; combination products must be registered as either pharmaceutical products or medical devices. For drug/device combinations; significant problems can arise in understanding an unfamiliar regulatory environment; product design; corporate collaborations and much else. This course provides useful insights into requirements for devices to improve your understanding of additional aspects to be incorporated into your dossier. Over two days; you will work to understand the medical device world as it applies to your drug/device combination; including risk management; clinical considerations and design control. The course will also feature a session on collaborating with partners in the device world to improve outcomes for your products.

  • Clinical Research Project Management

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Setting up and running clinical trials is a complex; timely and costly process. It is essential to manage your clinical projects with streamline efficiency to ensure they are completed within set timeframes and to budget. With this in mind clinical professionals are increasingly looking for ways to improve the results of their clinical projects by implementing project management techniques. Over three days this course will examine key management techniques such as analysing stakeholders; assessing risk/benefits and management style. Clinical project management examples; exercises and discussions will be used throughout the course to maximise your understanding of this essential skill. This course is also available for studying online.

  • Clinical Research Project Management - Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Setting up and running clinical trials is a complex; timely and costly process. It is essential to manage your clinical projects with streamline efficiency to ensure they are completed within set timeframes and to budget. With this in mind; clinical professionals are increasingly looking for ways to improve the results of their clinical projects by implementing project management techniques. Over 8 modules; this course will examine key management techniques such as analysing stakeholders; assessing risk/benefits and management style. This course is also available as a public training course.

  • Comparability For Biologics

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 2-day course provides valuable insight into the quality; safety; efficacy and regulatory impact of manufacturing changes and how to manage process change to guarantee regulatory compliance and product consistency at all times. It features numerous case studies from industry and practical advice from our experienced professionals on the best ways to satisfy the needs of the regulators and understand how various process changes may impact the success of your products.

  • Dissolution Testing

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Dissolution testing poses a major challenge to the pharmaceutical; biotech and generics industries both in terms of method development and regulatory compliance. This two-day training course will explain the history; benefits; importance and role of dissolution testing in drug development today. Using practical examples and case studies throughout; delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing. Clarify global regulatory requirements; Assess new scientific developments and trends; Design optimum method development strategies; Identify the factors affecting dissolution; Drive product performance and quality control; Study design considerations for IVIVC Studies. This course is also available for studying online.

  • Dissolution Testing Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 5-week online course will explain the history; benefits; importance and role of dissolution testing in drug development today. Using practical examples and case studies throughout; delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing. Clarify global regulatory requirements; Assess new scientific developments and trends; Design optimum method development strategies; Identify the factors affecting dissolution; Drive product performance and quality control; Study design considerations for IVIVC Studies ; A whole module devoted to case study examples.

  • eCTD Submissions

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Filing new submissions is a time consuming; laborious task for both industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the process. Using the eCTD has been proven to speed your data through the approval process; saving you valuable resources and time. Global regulatory agencies are committed to implementing the eCTD as standard. Attend this practical 2-day course and ensure your applications are in the correct electronic format and style from the onset.

  • Effectively Managing Vendor Oversight Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Using a combination of theory and practical examples; this essential 10-module course will provide a crucial overview of your responsibilities as a sponsor; giving you the knowledge you need to ensure quality oversight over 5 weeks. This course is also available as a public training course.

  • EU & US Requirements For Pharmaceutical Labelling & Package Leaflets

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This three-day course will clarify the European and US regulatory requirements for developing labelling and package leaflets and clearly interpret the latest Directive. The course will also provide practical advice on designing and writing Patient Information Leaflets and Package Inserts to meet regulatory requirements and satisfy readability and compliance needs. In the face of increasing regulatory and consumer demand; the need for accurate and complete product information has never been stronger. This course will provide you with key practical information on devising successful labelling strategies to guarantee complete compliance.

  • Examining The Q3D Guideline On Elemental Impurities Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This course will provide you with a comprehensive understanding of the ICH Q3D guideline on elemental impurities; to tackle its December 2017 implementation for approved products. Over four modules; you will examine the guideline and its scope in depth; evaluate the current challenges in implementation and receive guidance on constructing solid risk assessments. You will also be guided through relevant case study examples.

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