Tag Archives: Inspection

Health Canada releases draft guidance on classification of observations for inspection of cells, tissues and organs establishments

Posted on February 8, 2012 by damienbove| Leave a comment

Health Canada has released a draft guidance to assist with companies become compliant with the safety of human cells, tissues and organs for transplantation regulations which came into force on 7 December 2007. The purpose of this regulatory initiative is to minimise the potential health risks to Canadian recipient of human cells and tissues and organs. And to ensure that such organisations remain compliant with the proposed regulations.

More information is available on the Health Canada website

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Posted in biotechnology, manufacturing

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Health Canada Publishes a Document on Reviewing the Medical Device Inspection Cycle

Posted on October 23, 2011 by admin| Leave a comment

Health Canada Publishes a Document on Reviewing the Medical Device Inspection Cycle

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Health Canada is in the process of creating a Medical Devices Inspection Cycle. Our goal is to make this inspection cycle risk-based. This document provides potential options in inspecting scheduling and cycles.
We are exploring changes and we would appreciate your input on key concepts that we are considering. Specially, we welcome input on (i) how we assess the risk of an establishment; (ii) appropriate inspection cycles for different levels of risk.
The following suggestions may help you prepare your comments:

  • Please explain your views as clearly and concisely as possible.
  • Be sure to distinguish between what you support and what you object to in this document.
  • Provide rationale for your views, particularly your concerns, with facts, data or specific examples.
  • Describe any assumptions that you made.

Please submit your comments by November 16, 2011.
In order to provide your comments you must submit them by sending the Word or PDF format and email them to the mdcu-ucim@hc-sc.gc.ca.
Please note that any information collected will only be used for input to this consultation. The information collected will be used to create a summary report and will guide recommendations made as part of this review. The summary report will be made available to stakeholders once consultations are complete.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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EMA and FDA Seek Candidate for Joint GMP Inspection Programme

Posted on September 2, 2010 by admin| Leave a comment

EMA and FDA Seek Candidate for Joint GMP Inspection Programme.

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The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same medicinal product to both the EMA and the US FDA can request to participate in the pilot programme for joint pre-approval inspection should such an inspection be considered necessary by both agencies.

The overall objective is to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication.

Companies can also participate in the pilot exercise by hosting a single join re-inspection (routine surveillance) where both the EMA and the US FDA have separately planned routine surveillance inspections (re-inspections) to take place within a similar time period at a manufacturing site of a medicinal product authorised in the USA and centrally authorised in the European Union.

Companies that wish to participate should contact either gmp@ema.europa.eu and/or CDERInternationalGMP@fda.hhs.gov.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Posted in manufacturing

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Drug Regulators Publish, Guidance on Use of Accredited Persons Under the Accredited Persons Inspection Programme

Posted on October 12, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance on Selection of Accredited Persons.

Manufacturer’s Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Manufacturers Of Medical Devices May Be Eligible To Have Third-Party Inspections Of Their Establishments

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the voluntary third-party inspection program initially established by law in 2002, and applicable to manufacturers of class II or class III medical devices who meet certain eligibility criteria (see 21 USC §374(g)). The Inspection by Accredited Persons Program (AP Program), allowed eligible manufacturers to elect to have third parties that have been accredited by FDA (Accredited Person or AP) conduct some of their inspections instead of FDA. Under that 2002 law, manufacturers of eligible medical devices requested prior approval to use an AP instead of FDA staff to conduct a Quality Systems (QS) regulation inspection of their facilities.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators International Collaberation on GCP Inspections

Posted on August 27, 2009 by admin| Leave a comment

FDA and EMEA have Agreed to Launch a Collaborative Initiative on International Good Clinical Practice Inspection.

The FDA and the EMEA will be sharing information on inspection planning, policy and outcomes and they will be collaboration on inspections.There is an EMEA press release here.

Announcing this pilot Thomas Lönngren, the European Medicines Agency’s Executive Director said: “This important initiative demonstrates the increasing collaboration between the European Medicines Agency and the FDA. It marks an important step to the building of a global regulatory network for supervision of clinical trials. By working together in a collaborative and synergistic manner GCP inspection resources can be used more efficiently.”

The Key Objectives Are:

  • To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
  • To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
  • To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators International Collaberation on GCP Inspections

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Posted in clinical, regulatory

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