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Interactive course building on project management methodology, technical tools & techniques to develop people management & communication skills that are critical for the success of pharmaceutical proj... more information | send enquiry

If you didn’t write it down, it didn’t happen! This is the position of FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from dis... more information | send enquiry

This course is specifically designed for Clinical Research Monitors (CRMs) and Clinical Research Auditors (CRAs) and others who need basic and expanded knowledge in FDA and ICH Regulations for Good Cl... more information | send enquiry

This course provides a background and understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. It will take you step-by-step through the DMF preparation p... more information | send enquiry

Introduces participants to the practicalities and realities of project management. Providing practical advice from trial set-up to delivering targets, the problems of performing clinical trials and ho... more information | send enquiry

Course Aim Managing and being involved projects is a common feature of the biotechnology business environment. The purpose of this course is to instil the foundation of effective project management fo... more information | send enquiry

This course will teach all attendees how to develop essential CMC tactics and techniques in preparation of the CMC Section of the IND and NDA. It will also provide a detailed overview of CMC require... more information | send enquiry

Introductory Methods. This part of the course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical ... more information | send enquiry

This course is directed toward, and geared for Analytical Development, Quality Control, Stability, Formulation and pre-Formulation professionals involved in developing and running stability tests for ... more information | send enquiry

This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied in designing stability programs from the early stages of product development all the way to app... more information | send enquiry

Upon completion of this course you will have gained a thorough understanding of FDA expectations for the activities required to deal with OOS results in a compliant manner. You will have the backgroun... more information | send enquiry

While the birth of ICH took place in 1990, it was not until 2000 that the 3 major regulatory agencies (FDA, EMEA, JMHWL) signed off on the Common Technical Document (CTD) format. ICH M4 was thus intr... more information | send enquiry

Course Co-ordinators: Gordon Wright, Partner, Elkington & Fife and Lorna Brazell, Partner, Bird & Bird Format 9 module self-study course By the end of this course you will understand the key rules rel... more information | send enquiry

The course is designed for all Scientists (managerial and laboratory) whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings w... more information | send enquiry

This two-day course has been designed as an introductory course on cGMP for pharmaceutical, biotech and medical device personnel. It will assist those who are responsible for compliance with FDA cGMP... more information | send enquiry

Who Should Attend This course is directed toward, and geared for those who assemble, supervise, or manage the preparation and submission of Abbreviated New Drug Applications (ANDAs). The course is su... more information | send enquiry

The course strategy is to introduce and detail the basic issues and questions of study design and analysis that one should consider when reading published journal articles. This course is designed t... more information | send enquiry

This course presents a comprehensive overview of process writing that the binding regulations require. There’s a tenet among regulatory bodies: “If you didn’t write it down, it didn’t happen,” and w... more information | send enquiry

This one-day course introduces participants to the background of GCP and the concept of GCP within GLP labs. It also creates a discussion forum on the practicalities and problems of performing clinic... more information | send enquiry