Drug Development Consultant & Regulatory Consultant

EMA Publish Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

adam.parker — Fri, 18 May 2012 15:01:10 +0000

The “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial”1 (‘detailed guidance CT-1’) sets out the requirements as regards data related to an investigational medicinal product (IMP) to be submitted with the request for a clinical trial authorisation in the IMP Dossier (IMPD).

For further details, please view the document below.

Next Strategic Report (after Orphan) – What is a Generic?

adam.parker — Thu, 17 May 2012 12:35:22 +0000

This Directive represents an important step towards achievement of the objective of the free movement of medicinal products. Further measures may abolish any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of experience gained, particularly in the above-mentioned Committee for Proprietary Medicinal Products.

For further details, please view the document below.

EMA Publish Human Medicines Highlights

adam.parker — Thu, 17 May 2012 12:28:54 +0000

This newsletter is addressed primarily to organisations representing patients,
consumers and healthcare professionals. It provides a summary of key
information relating to medicines for human use published during the
previous month by the European Medicines Agency.
Information is selected based on recommendations from consulted patients,
consumers and healthcare professionals, and does not necessarily cover all
relevant information published by the Agency.
To receive an e-mail alert when each new issue of the newsletter is
published, send a request to: HMHnewsletter@ema.europa.eu

Link to newsletters – http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/document_listing/document_listing_000331.jsp

The White Paper – Three Threats to Scientific Research

adam.parker — Thu, 17 May 2012 10:06:48 +0000

IDA has formed a close relationship with Re-base an expert data management company specialising in life science research management. To help celebrate this we are helping them bring this excellent white paper to your attention.

Overview of the white paper: ‘Three Threats to Scientific Research’:

The purpose of Scientific Research is to improve our quality of life by advancing knowledge about our bodies, the world we live in and the universe beyond it. This knowledge is acquired through discoveries and discoveries are driven by data. Therefore, the tools to manage the data are crucial to the success of a research institution. Ironically, this community has been neglected by software companies in terms of data management. Consequently research institutions must resort to in-house solutions. As a result three core threats emerge, combine, quickly spiral out of control and begin impacting the effectiveness of the entire institution. After many years in development a solution has emerged that eliminates these threats, and significantly improves the speed and accuracy of discoveries.

Download the copy here - http://www.re-base.net/whitepapers.cfm

MedTech TV Regulatory Updates from April 2012

damienbove — Wed, 16 May 2012 13:31:37 +0000

April 2012 medical technology regualtory updates. MedTech TV Continue reading →

Data Management for Life Science White Paper

damienbove — Wed, 16 May 2012 12:59:24 +0000

Overview of the white paper: ‘Three Threats to Scientific Research’:

-FIND IN HERE

EMA Publish Reflection Paper on the use of Starting Materials and Intermediates Collected from Different Sources in the Manufacturing of Biological Medicinal Products

adam.parker — Wed, 16 May 2012 12:24:27 +0000

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. All information, which is relevant to the evaluation of the medicinal product concerned, shall be included in the application. This includes also information related to the starting and raw materials used in the manufacture of a medicinal product.

For further details, please view the document below.

EMA Publish Questions and Answers on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products

adam.parker — Wed, 16 May 2012 12:21:51 +0000

In the guideline on quality of herbal medicinal products (CPMP/QWP/2819/00/Rev. 1) it is stated that for herbal medicinal products with constituents of known therapeutic activity, the variation at the end of shelf-life should not exceed ± 5% of the declared assay value. Furthermore, according to paragraph 2.5 of the guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products (CPMP/QWP/2820/00 Rev. 1) only “in exceptional cases” different acceptance criteria for release versus shelf-life specifications apply. Because the European Pharmacopoeia (Ph. Eur.) allows standardisation for herbal preparations with constituents of known therapeutic activity, the HMPC is of the opinion ± 5% of the declared assay also applies at release.

For further details, please view the document below.

EMA Publish ICH Quality IWG Points to consider for ICH Q8/Q9/Q10 Guidelines

adam.parker — Wed, 16 May 2012 12:12:52 +0000

The ‘points to consider’ are based on questions raised during the ICH Q-IWG training workshop sessions in the three regions. The points to consider are not intended to be new guidelines. They are intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations.

For further details, please view the document below.

EMA Publish Appendix IV

adam.parker — Wed, 16 May 2012 12:07:38 +0000

Terms for batch number & expiry date to be used on outer and/or inner labelling

For further details, please view the document below.