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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

  • Regulatory; Developmental And Manufacturing Challenges For ATMPs

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This two-day course will provide you with a practical understanding of regulatory challenges; manufacturing concerns and clinical trial preparation for ATMPs. Using case studies and relevant examples; the course will improve your understanding of the regulatory landscape and provide you with approval routes for your product. In addition; you will gain a comprehensive understanding of the principal difficulties in delivery and shipping; applying GMP in manufacturing and getting ready for clinical trial. Delegates may choose to attend either one or both days of the course.

  • Risk Based Monitoring And Targeted SDV Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Implementing the most efficient strategies for monitoring is crucial to reduce the risks and costs associated with your clinical trial – it is estimated that sponsors can save 23% of trial costs with a risk-based approach. This course will assess the practicalities of implementing a risk-based approach and will demonstrate how risk based monitoring can contribute to better oversight of your clinical studies. Over 4 weeks you will explore the requirements for risk-based monitoring and targeted Source Data Verification (SDV) including which factors influence the scope of on-site SDV vs. remote SDV. Monitoring aspects will be assessed based on a standard risk assessment for investigational sites and how it can be applied.

  • Stability Testing For Pharmaceuticals

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Stability failures are responsible for a third of product recalls; costing pharmaceutical companies millions. The risk of not conducting thorough stability testing therefore outweighs the cost of performing it. This interactive 2-day course will provide you with an understanding of the science behind stability testing; a detailed examination of the ICH guidelines; accurate assessments of the tools and techniques to carry out testing. The course will also highlight the fundamentals you need to consider and can transfer back to your work place. This course is approved by the Royal Society of Chemistry.

  • Understanding And Preparing The Quality And Pharmaceutical Module Of The Global Ctd Dossier

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    This 3-day course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application; and will show you how to compile this important part of your submission dossier. This course will teach you how to: Compile and submit Module 3 (CTD) of your registration dossier; Ensure that Module 3 (CTD) of your dossier contains all data needed; Achieve the quickest turnaround for your submission; Deal effectively with regulators. Become more confident in your daily practices after three days of intensive lectures; group work; and discussion sessions; covering everything you need to know about compiling the chemistry and pharmacy section of your dossier. This course is also available for studying online.

  • Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier Online Academy

    Online Course | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    The Quality and Pharmaceutical Module (Module 3) of the CTD is challenging and requires considerable expertise to comfortably manage it. This detailed; 10 module course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 of your application; and will show you how to compile this important part of your submission dossier. This course will teach you how to: Complete and submit Module 3 (CTD) of your registration dossier; Ensure the correct structure is achieved for Module 3 (CTD); Achieve the quickest turnaround for your submission; Deal effectively with regulators. Over 5 weeks; completing 2 modules per week; become confident compiling the Quality and Pharmaceutical section of your dossier. This course is also available as a public training course.

  • US-FDA Drug Submission Procedures

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Tougher regulatory approval processes pose potential set-backs for pharmaceutical companies registering drugs in the USA . . . can you afford to waste your R&D investment by delaying your product launch? In the challenging environment of US drug registrations procedures; you and your colleagues need to understand all the current procedures. To help you do this; PTI has developed this course that will clarify the US regulatory process. By attending this extensive two day course; you will be able to gain a practical insight into FDA’s requirements for new drug development and prepare your new drug registration dossier accordingly to US guidelines.

  • Introduction To Regulatory Affairs In The MENA Region

    Workshop | Pharmaceutical Training International (PTI)

    Pharmaceutical Training International (PTI)

    Using a combination of theory and practical case studies; this course will allow delegates to develop the knowledge needed to successfully navigate the pharmaceutical market in MENA. Over the two days you will cover specific regulatory requirements; new developments or particular questions of interest within the region and countries to be discussed will include: North Africa – Morocco; Tunisia; Algeria; Libya and Egypt; Middle East – Kingdom of Saudi Arabia; Kuwait; Bahrain; Qatar; United Arab Emirates; Oman and Yemen; Near East – Jordan; Lebanon and Iraq; Eurasia – Turkey.

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