Regulatory Compliance Course Nov.29-Dec.27

A course on Regulatory Strategies and Compliance in the Development of Drugs & Biotechnology-Derived Products will be held at the Leonardo City Tower, 14 Zisman Street ,Ramat-Gan on 29 November, 06, 20 and 27 December 2012. The instructor is Dr. Moshe Neuman, PhD, CEO & President of B.R.D.– Bio Medical Research Design Ltd.

Course Description

Many medicinal products were not granted authorization due to a wrong development plan and/or a regulatory strategy chosen during the product early research and development phase. In many other cases the application submitted to the authorities did not contain all the required information, did not follow the content and format guidelines and therefore did not enable review process initiation, required multiple amendments and sometimes was returned to the sponsor.

This course is specifically designed to cover a broad description of the regulation of investigational new drugs and biologics, the basics of submission of applications seeking marketing approval for pharmaceuticals and biotechnology products, and post-marketing regulatory requirements required in the US and EU. This course will also review and enhance participants understanding of the different research and development milestones and regulatory procedures during the preclinical and clinical product development throughout registration file submission and its review by the health authorities FDA (US) / EMA (EU).

The course is an instructor-led, comprehensive, interactive, practical resource, tailored to your specific needs in pharmaceuticals and biotechnology regulatory affairs. This course emphasizes integrated product development which is science-based, efficient, economical, high quality and rapid – leading to better and safer medical products for patients.

All course participants will be receiving specially prepared course manual (full course presentation, including reference of main FDA / EU guidelines, form samples and links to all of the FDA /EU materials).

Who Should Attend this Course?

This Course is targeted for the pharmaceutical and biopharmaceutical industry, academic and government scientists, and decision and policy-makers in the biotechnology industry. This includes but is not limited to: Pharmaceutical and Biopharmaceutical Start-Ups Enterprisers and/or Executives, Heads of Research and/or Product Development Managers, QA Team Leaders, Regulatory Scientists from Industry, Academia and Government, Venture Funds and Financial Institutions Business Executives.

Course Length & Dates

This course consists of a total of 32 hours of lectures and hands-on activities over a 4 days period between 08:00 – 16:00. The course dates are: 29 Novenber, 06, 20 and 27 December 2012.

Course Location & Hospitality

The course will be using the facilities of the Leonardo City Tower, 14 Zisman Street ,Ramat-Gan 52136, ISRAEL. Refreshments and lunch are provided in all course days.

About the Course Instructor

Dr. Moshe Neuman, PhD, is the CEO & President of B.R.D.– Bio Medical Research Design Ltd. An Israeli independent professional consultancy company, dedicated to offering short-term and long-term consulting services to the pharmaceutical, biotechnology, medical device and other related industries. Dr Neuman has over 18 years of practical experience in the pharmaceutical industry, pre-clinical development and primarily in clinical studies QA management. Dr Neuman is experienced in the development and regulation of drugs, biologics, medical devices and combination products, specializing in quality assurance, regulatory affairs and serves also as an international auditor for clinical trials.

Course Certificate

To record your participation, B.R.D. will issue all course participants with a certificate of attendance upon the successful completion of this course. This certificate will testify your endeavour in career and professional development and is intended to contribute towards your career advancement.

Course Fee

The total cost for this 4 days course is 5,200 INS plus VAT per participant. The course fee covers training, course materials and lunch and refreshments for all course days. Companies may reserve participant slots with a group discount payment – available on request. Payment of the full course fee is required at time of booking in order to secure your place.

For more information contact 08-9366700

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