Abridged Applications, The Regulator and the Industry view, an intensive course examing the current requirements and current problems for those with a basic knowledge of the application procedure.
In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring
This In-house course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience.
An insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS.
An introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development.
This In-house training programme is ideal for non-Scientists and Scientists needing to understand the basic theory, principles, techniques and potential of biotechnology.
The 15 new EU modules concerning Pharmacovigilance are a major departure in terms of the way Pharmacovigilance is conducted in Europe. The intention of the course is to look at these modules and their requirements, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training; changes and introduction of SOPs; and the links to other Departments – not just Pharmacovigilance but also including Clinical; Medical Information; Marketing; IT; Quality; Regulatory; Training and GMP.
Some of the topics to be covered at this meeting include overview of the legal/policy landscape as it affects the terms of CTAs, clause by clause review, legal clauses, review of a Universitys CTA
This In-house course provides practical guidance on borderline issues and combination products
This one-day In-house training programme will provide your team with a practical guide to the foundations of effective technical writing and editing and apply them to your role in the workplace.
This In-house programme will provide your team with a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.
Train your team to understand the importance of accuracy and attention to detail in day-to-day work with this one-day In-house programme.
Covering Latest Developments and Hot Topics – consolidate your understanding of the issues that challenge companies in the current regulatory environment
With this In-house training your tream will learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource. Also covered will be the techniques for successfully managing CROs/vendors and the shared responsibilities required by the sponsor and the service provider.
Pharmaceutical Regulatory Affairs in Latin America a comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin Americal countries
A one-day programme which looks at the basic principles of Pharmacoepidemiology together with their practical application
In this In-house course be guided through topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
This two day In-house programme will help you gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment
This In-house project management course has been designed specifically for the Bio/Pharma Industry and is also applicable to those in medical device and animal health industries. It will provide your team with a thorough understanding of project management skills, including both technical and interpersonal skills.
This two day in-house training programme provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support role.
This In-house programme will show the team how to design efficient stability studies that are suitable for global marketing, and how to carry out appropriate stability studies and manage stability samples and facilities.
This In-house programme will show your team the new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites all at a location of your choice. Our expert comes to you and running this programme for your whole team is extremely cost-effective.
This three-day In-house Mini MBA management programme is a distillation of the most valuable parts of an MBA, as applied to the Bio/Pharmaceutical industry. It will provide your management team with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with Pharma case studies from business schools.
Variations to Marketing Authorisations in the EU, review of the Variations regulations. Update on Mutual Recognition/Decentralised, Centralised and National Variations (with emphasis on UK and Ireland).