Monthly Archives: October 2009

FDA Publishes New Guidance Page – Memoranda to Blood Establishments

Posted on October 31, 2009 by admin| Leave a comment

FDA Publishes New Web Guidance Page – Memoranda to Blood Establishments

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Blood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.

The memoranda on this page are arranged in order by date, with the most recent memo added to the top of the list.

<p class=”MsoNormal”>If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com</p>

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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<div id=”_mcePaste” style=”overflow: hidden; position: absolute; left: -10000px; top: 0px; width: 1px; height: 1px;”>recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.</div>

<dl id=”attachment_191″ class=”wp-caption aligncenter” style=”display: block; margin-left: auto; margin-right: auto; text-align: center; background-color: #f3f3f3; padding-top: 4px; margin-top: 10px; margin-bottom: 10px; -webkit-border-top-right-radius: 3px 3px; -webkit-border-top-left-radius: 3px 3px; -webkit-border-bottom-left-radius: 3px 3px; -webkit-border-bottom-right-radius: 3px 3px; border: 1px solid #dddddd;”> <dt class=”wp-caption-dt”><a href=”http://www.damienbove.com/?page_id=183″><img class=”size-full wp-image-191″ style=”padding: 0px; margin: 0px; border: 0px none initial;” title=”Free Strategy Consultation – Biotech Pharma Regualtory” src=”http://www.damienbove.com/wordpress/wp-content/uploads/2009/04/ida_consultants_freestrategyconsultation_515x64.jpg” alt=”Free Strategy Consultation – Biotech Pharma Regualtory” width=”515″ height=”64″ /></a></dt> </dl>

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 Publish Guidance for Allogenic Pancreatic Islet Cell Products

Posted on October 30, 2009 by admin| Leave a comment

Drug Regulators,FDA, Publish Guidance for Allogenic Pancreatic Islet Cell Products

Full Text Here

This guidance provides recommendations to manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus. The FDA, are issuing this guidance to assist with identifying data and information obtained during investigational new drug (IND) studies that might be helpful in establishing the safety, purity, and potency of a biological product. This guidance is not intended to identify all of the product, preclinical, and clinical data that might be needed to successfully support a biologics license application (BLA). This guidance finalizes the draft guidance of the same title, dated May 2008.

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 Publish Draft Guidance on Development, Analysis and Presentaion of Microbological Data for Systemic Antibarterial Drugs

Posted on October 29, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance For Systemic Antibaterial Agents

Full Text Here

The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. This guidance is intended to serve as a focus for continued discussions among the Office of Antimicrobial Products, pharmaceutical sponsors and applicants, the academic community, and the public. Recommendations in this guidance cover three major areas: (1) conducting general nonclinical studies; (2) conducting animal and human studies and clinical trials; and (3) establishing and updating in vitro susceptibility test methods, quality control parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.
This guidance does not address the development of antiviral, antifungal, antiparasitic, or antimycobacterial agents or antibacterials administered by nonsystemic routes (e.g., topical). This guidance is not meant to provide details on clinical trial design.

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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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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Drug Regulators Publish Guidance on End-of-Phase 2a Meetings

Posted on October 28, 2009 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on End-of-Phase 2a Meetings

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This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, placebo group responses, disease), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.
An EOP2A meeting would occur after the completion of clinical trials that provide data on the relationship of dosing and response for the particular intended use (including trials on the impact of dose ranging on safety, biomarkers, and proof of concept). For the purposes of this guidance, end of phase 2A occurs after the completion of phase 1 trials and the first set of exposure-response trials in patients, and before beginning phase 2B (i.e., patient dose-ranging trial) and phase 3 clinical efficacy-safety trials. In the context of drug development programs, discussions at an EOP2A meeting could include exploration of dose estimation and dose selection to use in late stage efficacy trials. Where novel trial designs are a possibility, their utility and applicability could be discussed at an EOP2A meeting.
This guidance focuses on the following specific topics:
● Objectives of the EOP2A meeting
● Considerations for evaluating EOP2A meeting requests
● Useful information for an EOP2A meeting package
● EOP2A meeting arrangements

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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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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Drug Regulators Publish Draft Guidance on Biosimilars for Recombinant Erthropoietins

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

Drug Regulators, EMEA, Publish Draft Guidance on the Development of Biosimilars for Recombinant Erthropoietins

Full Text Here

This guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as the risk management plan. Criteria for extrapolation of clinical data to other indications approved for the reference medicinal product are discussed.

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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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 Publish Draft Guidance on Biosimilars for Recombinant Erthropoietins

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Drug Regulators Publish Draft Clinical Guidelines for Cancer Vaccines

Posted on October 26, 2009 by admin| Leave a comment

Drug Regulators, FDA CBER, Publish Draft Clinical Guidance for Cancer Vaccines.

full text here

This guidance provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine, recommendations on critical clinical considerations for investigational studies of these products. This guidance will discuss considerations common to phase 1 and phase 2 clinical trials (which collectively may be referred to as “early phase clinical trials”) and phase 3 clinical trials (which may be referred to as “late phase clinical trials”) and that are unique to specific stages of clinical development of these biological products.
The products discussed in this guidance are for therapeutic cancer vaccines, referred to as “cancer vaccines” throughout this document, intended to be administered to patients with an existing cancer for the purpose of treatment. This guidance does not apply to products intended to be administered to patients to prevent or decrease the incidence of cancer. Furthermore, this guidance does not apply to adoptive immunotherapeutic products such as T cell or NK cell products. Although clinical trials involving these products share certain overlapping features with those involving cancer vaccines, adoptive immunotherapeutic products have different mechanisms of action and unique requirements with respect to product development.

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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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 Publish Draft Clinical Guidelines for Cancer Vaccines

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Twitter Weekly Updates for 2009-10-25

Posted on October 25, 2009 by admin| Leave a comment
  • Presenting a business plan is more than the science! And more than market sizes! Its alllll about dynamics! Its just so important! #

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Drug Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Posted on October 22, 2009 by admin| Leave a comment

Drug EMEA Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Two guidelines have been developed by the Vaccine Working Party (VWP) on Pandemic
Influenza vaccines:
- Guideline on dossier structure and content for marketing authorisations for pandemic
influenza vaccines (EMEA/CPMP/VEG/4717/03 Rev-1);
- Guideline on submission of marketing authorisation applications for pandemic
influenza vaccines through the centralised procedure (EMEA/CPMP/VEG/4986/03).
This harmonised SPC has been developed by the VWP in order to facilitate the submission of
the core pandemic dossier and subsequent approval of the pandemic variation: the SPC, based
upon this harmonised SPC proposal, labels and package leaflet approved in the core pandemic
dossier authorisation will normally not have to change (except for some information on the
pandemic strain) when the pandemic variation is submitted. It is intended solely for
inactivated pandemic virus derived vaccines. Please note that the text proposal should be
considered as a minimum requirement. Additional claims should be substantiated with data.
It should be read in conjunction with the following additional guidance documents:
- Guideline on Summary of Product Characteristics, published by the European
Commission
- Guideline on Pharmaceutical aspects of the product information for human vaccines
(EMEA/CPMP/BWP/2758/02)
- QRD Product Information Template with explanatory notes
- Convention to be followed for QRD Templates

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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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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Drug Regulators Publish Q&A on ICH M2 – Common Technical Document for the Registration of Pharmaceuticals for Human Use

Posted on October 21, 2009 by admin| Leave a comment

Drug Regulators EMEA Publish Q&A on ICH M2 – Common Technical Document for the Registration of Pharmaceuticals for Human Use

This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification.  The questions answered here relate to common questions that relate to the eCTD in all three ICH regions.  Many of the questions received on the Step 2 specification were addressed in Step 4 and do not appear in the list.   Questions concerning the timeframe for implementation of region-specific application types, module 1 implementation, lifecycle management and those questions that relate to items in the specification that direct the reader to each region are answered in guidance documents published for each region.

Questions related to the table of contents for the Common Technical Document (CTD) should be directed to the CTD question and answer section of the ICH Website.

Some of the questions posed so far address change requests to the eCTD Specification.  The change request section of this document addresses all those items received by the eCTD IWG and indicates their status.

This document will be updated as the specification undergoes change control or as new questions are submitted to the eCTD IWG.

It is available on the EMEA website, or email me asking for 082003en and I will send you a copy.

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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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 Publish Q&A on ICH M2 Common Technical Document for the Registration of Pharmaceuticals for Human Use

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Drug Regulators Publish Draft Guidance on Development of Similar Recombinant Erythroproetins Containing Prodcuts

Posted on October 20, 2009 by admin| Leave a comment

Drug Regulators EMEA publish Guidance on the Development of Similar Biological Products Containing Erythropoietins.

Full Guidance Here.

This guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as the risk management plan. Criteria for extrapolation of clinical data to other indications approved for the reference medicinal product are discussed.

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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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 Publish Draft Guidance on Development of Similar Recombinant Erythroproetins Containing Prodcuts

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Parallel Scientific Advice at the Regualtors

Posted on October 19, 2009 by admin| Leave a comment

FDA and EMEA have a Parallel Scientific Advice Procedure – Reminder

Just a reminder that the FDA CBER (centre for biological evaluation and research) and EMEA have a combined scientific advice procedure. It is a pilot programme at the moment and is developed to offer a parallel process to industry.

On September 17, 2004, the EMEA and the FDA agreed to undertake a pilot program to provide parallel scientific advice (PSA). The pilot began on January 1, 2005 and was extended per agreement of both parties on March 13, 2006. For the FDA, this program aligns most closely to pre-IND/end of Phase II meetings. During this pilot, PSA efforts should focus primarily on important breakthrough products. The expected advantages from such interactions are.

  • increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product,
  • a deeper understanding of the bases of scientific advice, and
  • the opportunity to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies.

These meetings are conducted under the auspices of the confidentiality arrangement between the European Commission, the EMEA, and FDA. The complete text of the agreed upon general principles for the pilot can be found at the General Principles EMEA – FDA Parallel Scientific Advice Meetings Pilot Program website.

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.

ida 100programme 515x64 LowRes Parallel Scientific Advice at the Regualtors

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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 Parallel Scientific Advice at the Regualtors

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Twitter Weekly Updates for 2009-10-18

Posted on October 18, 2009 by admin| Leave a comment
  • Contracting out specific project elements to independent experts means we can offer a full service with high expertise in all areas! #
  • Orphan presentations should include all that an orphan application contains! Emea and FDA combined applications! #
  • Indication selection needs be be inclusive and broad if it is to make sense! #
  • Ideas only have value when you implement and share Them and that goes double in science! But keep confidential until your patented! #

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Drug Regulators Publish Guidance on Tacrolimus Development

Posted on October 18, 2009 by admin| Leave a comment

Drug Regulators Publish Guidance on Tacrolimus Development Programmes.

The FDA has published a one-page guidance document on he bioequivalance development plans for Tactolimus.

Full Text Here.

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 Regualtors Publish Intnetion to Change Regualtiosn on Sale, Supply and Administration of Drus and Dental Hygenists and Dental Therapists

Posted on October 17, 2009 by admin| Leave a comment

UK Drug Regulators Consult on Changes to the Regulation of Dental Hygienists and Dental Therapists

Full Text Here.

In accordance with section 129(6) of the Medicines Act 1968 about proposals to amend medicines legislation to enable Dental Hygienists and Dental Therapists to sell, supply and administer medicines under a Patient Group Direction (PGD). The consultation abides by the seven consultation criteria set out in the Government’s Code of Practice on Consultation.
2. Following the consultation, the Commission on Human Medicines (CHM) will be asked to make formal recommendations to Ministers, in light of the responses received, on the proposals. The proposals, if agreed, will be achieved by amendments to the Prescription Only Medicines for (Human Use) Order 1997, (the POM Order), the Medicine (Pharmacy and General Sale – Exemption) Order 1980 and the Medicines (Sale and Supply) (Miscellaneous Provisions) Regulations 1980.

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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European Medicines Agency implements internal reorganisation

Posted on October 16, 2009 by admin| Leave a comment

PRESS RELEASE
European Medicines Agency implements internal reorganisation

The European Medicines Agency has begun implementing a series of changes to its internal  organisation aimed at improving the functioning of the Agency and the way in which it delivers its  core tasks. The changes will be introduced gradually from September to December 2009.  In line with its increased responsibilities, the Agency has developed over the past years in terms of  staff numbers and internal processes. The number of scientific committees and the complexity of  procedures have also grown, and the cross-relationship between committees brings with it the need for enhanced coordination. In addition, future legislative proposals are expected to bring further responsibilities to the Agency.
Following an Agency-wide process improvement exercise initiated in 2006, from May 2007 attention focused specifically on core business – examining processes within the two units dealing with medicinal products for human use and monitoring their interactions in order to assess their potential for adapting to future needs.

  • The resulting reorganisation includes the following key changes:
  • The life-cycle management of medicines for human use is brought together into one Unit, HumanMedicines Development and Evaluation, led by Patrick Le Courtois and responsible for the provision of advice during R&D, through to management of the review process and changes to products after they have been approved
    The creation of a Unit, Patient Health Protection, led by Noël Wathion, contributing to patient  health protection from the multiple perspectives of pharmacovigilance, risk and crisis
    management, patient and health care professional information, inspections (for both human and veterinary products), and appropriate regulatory compliance. The Unit will also be in charge of  community procedures for both centrally and non-centrally authorised products
  • Within the Unit for Veterinary Medicines and Product Data Management, led by David Mackay:
  • creation of a single Sector responsible for all areas of veterinary medicines – development, evaluation and maintenance of veterinary medicines, public and animal health (including
    safety) and veterinary regulatory affairs
  • creation of a single Sector for the management of product data and documentation related to applications for the whole Agency; it will also be involved in the development of IT systems to support scientific business processes
    Rationalisation of services within the Unit for Information and Communications Technology, led by Hans-Georg Wagner and within the Administration Unit, led by Andreas Pott

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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The Human Fertilisation and Embryology Act Comes into Force

Posted on October 16, 2009 by admin| Leave a comment

The Human Fertilisation and Embryology Act Comes into Force

The Human Fertilisation and Embryology Act 2008 comes into force on Thursday 1 October – ensuring the UK remains at the forefront of developments in treatment and research.

The 2008 Act responds to changes in society and ensures it is fit for purpose in the 21st Century.

Government undertook a review of the 1990 Act, bringing legislation up to date with society, and to reflect technological developments, such as new ways of creating embryos. It enables scientists to investigate cures for serious illnesses such as Parkinson’s disease and regulate assisted reproductive treatments.

Public Health Minister Gillian Merron said:

“This landmark legislation ensures that the UK remains at the forefront of scientific advances in this field, now and into the future. The Act has already touched so many lives – ensuring scientists have the opportunity to work on discovering new cures for devastating illnesses, and offering others the chance to have a much wanted family.

“This Act is proof that scientific progress can be balanced with the rights of individuals and proper controls.”

The 2008 Act

·        Ensures that all human embryos outside the body – whatever the process used in their creation – are subject to regulation.

·        Ensures regulation of “human-admixed” embryos, which are created from a combination of human and animal genetic material for stem cell research.

·        Bans sex selection of offspring for non-medical reasons.  This puts into statute a ban on non-medical sex selection which is currently in place as a matter of HFEA policy.  Sex selection is allowed for medical reasons only, for example to avoid a serious disease that affects only boys.

·        Recognises same-sex couples as legal parents of children conceived through the use of donated sperm, eggs or embryos. These provisions enable, for example, the civil partner of a woman who carries a child via IVF to be recognised as the child’s legal parent. These provisions came into force on 6 April 2009.

·        Values the role of all parents by retaining a duty to take account of the welfare of the child in providing fertility treatment, but replaces the reference to “the need for a father” with “the need for supportive parenting”.

·        Revises the restrictions on the use of HFEA-collected data to help enable follow-up research of infertility treatment.

·        Extends the time that embryos can be stored for, to up to 55 years in cases of premature infertility.

The 2008 Act maintains the regulatory system set out by the 1990 Act.

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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Pan African Registry is Given WHO Thumbs Up

Posted on October 16, 2009 by admin| Leave a comment

PRESS RELEASE: WHO provides primary status to the Pan African Clinical Trials Registry in Africa

The Pan-African Clinical Trials Registry (PACTR) has been accepted as a primary clinical trials registry – the first World Health Organization (WHO) endorsed trials registry in Africa. This registry will feed data into the global WHO International Clinical Trials Registry Platform (ICTRP) search portal facilitating African representation in the global picture of planned, ongoing and completed clinical trials. The Registry is currently funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and coordinated by the South African Cochrane Centre (SACC) at the Medical Research Council (MRC).

“We are delighted to be able to offer access to a WHO primary register to all trialists in Africa. We hope the PACTR will become the first choice for African trial registration,” says Nandi Siegfried, co-director at the SACC.

In September 2004, the International Committee of Medical Journal Editors (ICMJE) stated that all 11 member journals would adopt a registration policy to promote comprehensive trial registration as a solution to the problem of selective awareness (http://www.icmje.org/clintrial.pdf). Thus clinical trials must be publicly registered before the first participants are enrolled if the intention is to publish findings in member medical journals which include leading journals such as The Lancet, JAMA and NEJM.

Professor Charles Mgone, EDCTP Executive Director, explained that since June 2009 the African registry has expanded from a disease-specific registry to cater for clinical trials on all diseases transitioning to the PACTR. Researchers conducting clinical trials in Africa who use PACTR as their registry of choice will meet international requirements for research transparency.

Davina Ghersi, head of WHO’s International Clinical Trials Registry Platform (ICTRP), says the approval of PACTR as a primary trials registry is a significant milestone in the quest for transparency. “Our hope is that the PACTR will make it easier to capture information about trials involving people in the region. We look forward to filling the gap in our knowledge about clinical trials in Africa.”
Since registries “provide an essential tool to assess completeness of the information about all initiated trials” and are the “necessary first step to enable identification of all trials” and the “tracking of their results” (Moja et.al., http://www.trialsjournal.com/content/10/1/56), having an African based registry will benefit both Africa and the world as PACTR will actively encourage trial registration.

“Registering a clinical trial greatly increases exposure of the trial and assists researchers in determining gaps in research, thus reducing the likelihood of duplication of research and wasted funding and man-power,” says Professor Charles Mgone.

Dr Siegfried further says that it is the intention for PACTR to become the single reference point for clinical trials activities in Africa. ‘The registry will feed directly into the global WHO International Clinical Trials Search Portal, thus ensuring African representation in this global search engine’.

Additionally, the PACTR’s database will include regularly downloaded information from the South African National Clinical Trials Registry (SANCTR) and will continue to build information sharing networks with national or other localised registries.

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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METRC Announce Short Term Project Funding

Posted on October 16, 2009 by admin| Leave a comment

METRC Announce Short Term Project Funding £3000 going to £7000.

Short Term Project Funding is designed to support small research projects to explore the feasibility of innovative new products and processes. In the first stage, funds of up to £3,000 are available to support collaborative projects between METRC’s academic members and industry partners. The funding can be used flexibly at the METRC academic  institutions on a range of activities such as project consumables, paying for researchers or some limited consultancy work. For the most successful projects, funding can be extended into a second stage worth up to an additional £7,000 providing there is a matching contribution from an industrial partner.

he call will open on 16th October 2009 and funding will be available on a first-come first-served basis. We will be accepting applications for stage 2 funding from 1st January 2010 and there is funding available to support up to 10 stage 2 projects. We expect that a second tranche of Short Term Project Funding will be made available during 2010.

The Contacts Are:

Richard France – r.m.france@sheffield.ac.uk, 0114 222 9563
Simon Butler – simon.butler@sheffield.ac.uk, 0114 222 9450
Sam Whitehouse – S.P.Whitehouse@sheffield.ac.uk, 0114 222 9493

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 Publish Guidnace for Formal Meetings

Posted on October 16, 2009 by admin| Leave a comment

FDA publish guidance for formal meetings with industry.

Full test here.

This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference).
This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible.
This guidance supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000. The 2000 guidance implemented section 119(a) of the Food and Drug Administration Modernization Act of 1997, and reflected a unified approach to all formal multidisciplinary meetings between sponsors or applicants and the FDA.

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 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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