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EU extends grace period for transition to Medical Device Regulation
New course on good practices (GxP)
New courses on clinical trial safety reporting released
Fifty courses now available from Zenosis
New courses on clinical research under the EU Clinical Trials Regulation released
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Mon 15 Jul 2013 @ 10:54
Cooperation between LeoPink and Zwiers Regulatory Consultancy
Education and consultancy meet to increase regulatory effectiveness
LeoPink announces that it has entered into a strategic relationship with Zwiers Regulatory Consultancy BV. The co-operation will provide consultancy and education to support process, project and report management from early development to mature products.
Zwiers is headed up by Alex Zwiers who has many years of experience managing and coaching regulatory teams in major international companies.
Alex: “Working with LeoPink gives us the ability to deliver best practice to our clients in a cost effective and timely manner. This will improve the capability of the industry as a whole.”
Fardad Gharebaghi of LeoPink in his turn welcomes “this formal relationship with Zwiers which has been built over many years. By close cooperation in education and training, both organisations have helped clients successfully achieve their business objectives and goals.”
LeoPink is a technology learning company which provides an extensive library of Regulatory Affairs and Compliance courses to the pharmaceutical sector and is a pre-eminent leader in its field.
Zwiers Regulatory Consultancy provides full regulatory support throughout the entire drug lifecycle, including strategic advice, regulatory documents, training and staffing.
The New Drug Application (NDA) for Marketing Approval in the USA
Thu 11 Jul 2013 @ 11:01
Zenosis, the leading provider of specialized training solutions for the pharmaceutical industry has announced the release of a new e-course, The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
- A fresh new interface
- Audio support with animation
- Immersive activities throughout
A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA.
For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable?
This module provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.