Speaker Profile


Robert J. Russell

President, RJR Consulting, Inc.

Robert J. Russell For the past 9 years, He has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

  •  Wednesday, July 25, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

  •  Wednesday, August 1, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

  •  Friday, August 17, 2018
  • 12:00 PM PDT | 03:00 PM EDT,
  • 3 Hours
  • ¤290.00
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
The European Clinical Trial Directive (EUCTD)

The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
EU Pharmacovigilance Directive and Regulations

New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

  • Recorded
  • View Anytime
  • ¤190.00
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

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Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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  +1-800-447-9407
  support@compliance4All.com