Management Forum courses

...of whether the corrective and preventative actions have been implemented – has the organisation done what they said they would? If previous major findings... Learn about: Intellectual Property, Medical training, Process Improvement...

...New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance... Learn about: Management of Risk, IT risk, Risk Management...

...Benefits of Attending Understand the Legal Basis of the EU Regulatory Environment Discuss Development Strategy and Pre-Submission Activities Review Procedures... Learn about: EU Law, EU Regulations, Life Science...

...and Labelling •Advertising regulations •Bioequivalence •Biologic and biotechnology product regulations This seminar will be of particular interest to all... Learn about: Pharmaceutical Marketing, Life Science, Medical training...

...This one-day seminar is designed to help you deal with the difficult people in your working life – the people, particularly colleagues, who can be a minor... Learn about: Conflict Management, Management Planning, Pharmaceutical Management...

...– an Overview of Selection and Bidding Processes including Assessing the Competency of the CRO / Vendor All or none – what should you outsource?... Learn about: Contract research organization, Pharamaceutical marketing, Life Science...

...Generate a business plan that drives organisational activity • Increase the accuracy of forecasting • Ensure realistic forecasting • Allocate appropriate... Learn about: Pharmaceutical Management, Life Science, Conference planning...

...Pharmacovigilance activities Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance Types of SOPs required Production and sign off of... Learn about: Qualified Person, Pharmaceutical Regulations, Medical Devices...

...drug information and regulatory affairs departments, drug safety officers and pharmaceutical physicians as well as pharmacovigilance personnel working at regulatory agencies... Learn about: Pharmaceutical Marketing, Life Science, Medical Devices...

...Introduction to the parties to the CTA and key roles and responsibilities Policy issues in public hospitals, e.g. UK NHS approval Other ethical/legal issues Standard contracts... Learn about: Negotiation Skills, Medical Devices, Clinical Trial...

...mitigation Oversight of CROs New requirements for sponsor oversight of vendors/CROs Implications for the selection, contracts, management and performance... Learn about: Quality management, Quality Training, Clinical Trial...

...15.15 Refreshments 15.30 Clinical Issues and SmPC Review of data requirements: full versus abridged Line extension Bibliographical/Well Established... Learn about: Quality Training, Life Science, EU Law...

...reduction – and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines... Learn about: Food Handling, Medicine and Food...

...Engineered products Stay up-to-date on Post Market Surveillance for combinations products... Learn about: Legal expertise, Pharmaceutical Research, Training planning...

...in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspection This course would... Learn about: Life Science, IT risk, Risk Management...

...Drug and device development is a complex process which needs effective project management. With ever increasing pressures to complete the development... Learn about: Project Management, Pharmaceutical Research, Medical training...

...Increase your understanding of the Pharma industry Develop your knowledge of the stages of drug development from dug discovery through to marketing... Learn about: Medical Devices, Drug Development, Life Science...

...Authority and how to, when to, and what to communicate with the authority •Regulatory affairs specialists •Quality assurance specialists •Clinical research... Learn about: Adverse Event Reporting, Medical Devices, Clinical Studies...

...Benefits in Attending: Gain knowledge on Storage Tests, Conditions and Protocols n Learn how to design Protocols for global marketing Discover how to manage... Learn about: Stability Testing...

...a Process Validation programme Understand the link between Quality by Design and Process Validation Gain a practical, science and risk-based approach... Learn about: IT risk, Quality Training, Risk Assessment...