01-10-2013  - 02-10-2013

Content & Learning Objective In this one-and-a-half-day theory course, basic methods and strategies for the cloning of DNA fragments are explained in detail. Topics covered include: Cloning strategies: successful and efficient cloning Vectors: possibilities and choice (standard cloning ...

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07-10-2013  - 08-10-2013

At the end of the two-day course attendees will: Gain a firm understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH) for biopharmaceuticals and biologics; Appreciate the significant CMC regulatory differences between chemical-origin drugs and ...

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09-10-2013  - 10-10-2013

To better understand what the developing FDA biosimilar pathway might look like, this course will closely examine the existing regulatory guidelines from the European Medicine Agency (EMA) and the World Health Organization (WHO), and compare them to the draft FDA guidances. Insights and ...

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21-10-2013  - 22-10-2013

This course explores the international challenges of trial records management: people, culture, and systems. With so many trials occurring in Brazil, Russia, India, China, South Korea and Turkey, as well as the US, Canada and Europe, the confluence of cultures presents unique challenges. ...

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21-10-2013  - 22-10-2013

This course focuses on understanding and implementing the requirements of the EU Clinical Trial Directive. The course covers all relevant topics associated with the Directive, and a review of methods for effective implementation. The course consists of lecture and interactive exercises to ...

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21-10-2013  - 22-10-2013

This course is designed to provide attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. The topics discussed during the course will be presented to explain the physical, physicochemical, biochemical, and engineering principles of ...

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23-10-2013  - 25-10-2013

Efficient and effective management of Phase 1 and 2 clinical trials can significantly impact the time, scope and budget for the development of a drug or device. Project managers must understand the development process and the key aspects of Phase 1 and 2 in order to act, react and adapt to ...

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23-10-2013  - 25-10-2013

Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug. Topics include: Basic concepts of drug ...

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24-10-2013  - 25-10-2013

Initially, the course will discuss the regulatory expectations and other industrial references/ standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied ...

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28-10-2013  - 29-10-2013

If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory ...

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