Tag Archives: scientific advice

EMA SME Workshop, Scientific and Regulatory Advice

EMA SME Workshop, Scientific and Regulatory Advice

Full Text Here

26/05/2011 - 26/05/2011

The workshop presents the support available to SMEs during early drug development and highlight recent experience in quality, non-clinical and clinical scientific advice. In addition, the workshop covers regulatory support available prior to submission of an application for marketing authorisation.

For Assistance with Obtaining Scientific Advice or Regulatory Advice from EMA Click Here

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.

Fill Out the Short Form Below…


  1. (required)


  2. (valid email required)

“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.”

EMA, The European Drug Regulator, Publishes Guidance for Companies Requesting Scientific Advice and Protocol Assistance

EMA, The European Drug Regulator, Publishes Guidance for Companies Requesting Scientific Advice and Protocol Assistance

Full text Here

This guidance document addresses a number of questions that users of the Scientific Advice or Protocol Assistance procedures may have.
It provides an overview of the procedure to obtain Scientific Advice or Protocol Assistance and gives guidance to companies in preparing their request. This guidance document also explains the scope and nature of Scientific Advice and Protocol Assistance. It will enable companies to submit requests which are in conformity with Scientific Advice Working Party (SAWP) requirements and which can be validated and evaluated quickly and efficiently. Furthermore, companies will be guided through the different steps of the procedure and receive useful information on the preparation of a possible discussion meeting with the SAWP. This guidance document is updated regularly to reflect new developments and include accumulated experience. In particular, this version was amended to include:
• the possibility of scientific advice on changing the classification for the supply of a medicinal product (reclassification of Legal Status), Q3
• clarification of the collaboration between SAWP and PDCO for products undergoing scientific advice, Q5
• the possibility of parallel CHMP scientific advice/protocol assistance and advice from Health Technology Assessment bodies, Q25
• the European Medicines Agency’s (hereafter referred to as the Agency or the EMA) new corporate identity
• the introduction of a briefing document template
• updated fees

For Regulatory Services Click Here

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.

First name

Phone #1

E-mail address

“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.”

Drug Regulatros, MHRA, Publish Comment on Voluntary parallel scientific advice with NICE and the MHRA

Drug Regulatros, MHRA, Publish Comment on Voluntary parallel scientific advice with NICE and the MHRA

Full Text Here

The MHRA have been in discussion with the National Institute for Health and Clinical Excellence (NICE) about the possibility of running voluntary parallel scientific advice in relation to clinical trial programmes and have agreed to undertake a small pilot commencing March 2010.

Companies who are interested in being considered for this pilot should already have experience of MHRA and NICE scientific advice procedures for other products and should contact Ian Hudson at MHRA – ian.hudson@mhra.gsi.gov.uk – or Carole Longson/Seren Phillips at NICE.

Drug Development Planning Services

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.

<h1>Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!</h1>

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 <em>20 and 40 new regulations, rules and initiatives each month</em>, and summaries them in a fantastic <strong>FREE monthly Regulatory and Market Round Up</strong>. 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. <em>Just fill in the form below</em>.

<form action=”http://www.damienbove.com/cgi-bin/arp3/arp3-formcapture.pl” method=”POST”>

<div>

First name

<input name=”first_name” size=”20″ type=”text” /></div>

<div>

Phone #1

<input name=”phone1″ size=”20″ type=”text” /></div>

<div>

E-mail address

<input name=”email” size=”20″ type=”text” /></div>

<input name=”subscription_type” type=”hidden” value=”E” />

<div><input type=”submit” value=”Yes Please, Sign Me Up!” /></div>

<input name=”id” type=”hidden” value=”7″ />

<a href=”http://www.damienbove.com/free-strategic-review/”><img class=”size-full wp-image-191″ title=”Free Strategy Consultation – Biotech Pharma Regualtory” src=”http://www.damienbove.com/wordpress/wp-content/uploads/2009/04/ida_consultants_freestrategyconsultation_515x64.jpg” alt=”" width=”515″ height=”64″ /></a>

Free Strategy Consultation - Biotech Pharma Regualtory

<input name=”extra_ar” type=”hidden” value=”|2″ /> </form><em>“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.”</em>

<em><a href=”http://www.damienbove.com/how-to-write-a-business-plan/”><img class=”aligncenter size-full wp-image-640″ title=”How To Write A Business Plan” src=”http://www.damienbove.com/wordpress/wp-content/uploads/2009/07/ida_100programme_515x64_LowRes.jpg” alt=”" width=”515″ height=”64″ /></a>

</em>