The additional usage will be in order to put active immunisation in place against pneumonia for children from six weeks to five years old. GSK has submitted the application to the EMA as a variant to the marketing authorisation already in place.
Synfolrix is currently approved across the EU and in 90 other countries as an immunisation against invasive diseases and other illnesses caused by the same bacterium which can cause pneumonia in children under five. Over two thirds of these countries have already approved Synflorix for use against pneumonia.
The European Commission (EC) has granted approval to Eli Lilly for it’s drug Alimta as a single agent to act as maintenance therapy for those suffering from advanced nonsquamous non-small cell lung cancer (NSCLC) reports pharmaceutical-business-review.com.
Progression free survival was indicated to have improved in clinical trials conducted by Eli Lilly when the patients were treated with Alimta alone and this is what convinced the EC to grant approval to the drug. Continuation maintenance therapy will help those who have reacted positively to first line treatments of Alimta coupled with cisplatin designed to stabilize the disease.
Allen Melemed, senior director of Lilly’s Oncology department believes the approval will see distinct advancements in lung cancer treatments. Also, following first line treatments, patients have the opportunity to now continue treatments with the chance of “a better clinical outcome.”
The drug can now be used as a treatment on it’s own to treat patients with locally advanced or metastatic lung cancer. Prior studies have shown that Tarceva nearly doubles the amount of time patients survive without their cancer progressing when compared to chemotherapy.
Hal Barron, Roche’s head of Global Product Development and chief medical officer believes the European approval to be good news for those with genetically distinct forms of the cancer because they can receive a greater benefit when the medicine is used as an initial treatment.
Samarind RMS has been released in its fourth version by Samarind Limited, a provider of software to the regulatory affairs profession, reports PharmiWeb.com.
The new software is designed for worldwide usage rather than a solely European venture. Many companies are showing interest in the EudraVigilance Medicinal Product Dictionary software update, needed to fall in line with EMA regulations and are looking to submit their information to be included before the July 2012 deadline.
Samarind’s Phil Turner comments “Our objective remains to ensure that we align our software with the current and future needs of the regulatory affairs profession.” Samarind RMS reduces costs of managing licences and also increases profitability of said licences.
CK Regulatory are currently working with a number of excellent candidates looking for new positions in Regulatory Affairs. Please click on the job titles below to find out more:
As Senior Regulatory Affairs Associate you will be responsible for obtaining licences for new products and maintaining licences for existing products as well as the compilation and submission of clinical trial applications.
Main responsibilities:
Obtaining and maintaining product licences by filing submissions to regulatory agencies.
Provide answers to regulatory queries from the authorities.
Provide regulatory input to and compiling clinical trial applications, end of trial notifications and other relevant documents.
Using and updating corporate regulatory system database as required.
Build strong relationships with junior and intermediate staff in the local regulatory agency.
Provide excellent problem solving skills to complex issues.
Support Regional Regulatory Scientist for key assets.
Person Specification:
Life sciences degree.
Experience within pharmaceutical regulatory affairs.
Experience of compiling and submitting CTAs.
Knowledge of licence renewals and variations.
Excellent communication skills.
Ability to prioritise workload.
Apply Now
For more information or to apply for this Senior Regulatory Affairs Associate position, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.
The main purpose of this Regulatory Affairs Manager job will be to facilitate product development and global registration by helping to develop regulatory strategy for product manufacturing and quality programs from MAA to life cycle management.
Main Responsibilities:
Preparation of CMC sections for Emerging Markets filings, from MAA to post approval activities.
Contribute to CMC product teams, reports status and development of projects to teams and department.
Interact with authors and reviewers with respect to conformance of documents to regulatory and CMC requirements.
Consider how Emerging Market regional issues effect regulatory strategy for proposed CMC filings.
Monitor and assess impact of global regulations, guidance's and current regulatory environment and apply to job.
Develop and maintain templates for IE regional requirements.
Document CMC submissions and other communications in IMR.
Licensing support, may represent regulatory at due diligence meetings.
Person Specification:
Extensive hands on experience within the pharmaceutical or biotechnology industries.
Strong knowledge of regulatory affairs.
CMC specific regulatory knowledge and experience.
Direct experience with Emerging Market applications.
Creation of regional regulatory strategies.
Attention to detail.
Time and project management skills.
Problem solving.
Strong written and verbal skills.
Apply Now
For more information, or to apply for this Regulatory Affairs Manager job, please contact Meera Pattni at CK Clinical on +44 (0)1438 743047 or email mpattni@ckscience.co.uk.
A global pharmaceutical company are currently looking for an International Regulatory Affairs Executive to join their team in the South East, UK.
The main purpose of this International Regulatory Affairs Executive position is to apply broad knowledge and interpretation of regulatory requirements in assigned countries and products to the drug development process.
Further key responsibilities of this position include:
Assist in the preparation of International Regulatory Dossier submissions for NMEs.
Prepare IRDs for line extension.
Liaise with internal and external technical experts responsible for preparation of expert documentation.
Advise on the development of regulatory documentation that
Ensure that line management are advised of progress with in regulatory filings.
Apply Now
For more information, or to apply for this International Regulatory Affairs Executive job, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
Our client, a global pharma company, are currently looking for an Associate Director (Regulatory Operations) to join their team based in Berkshire, UK.
Reporting to the Executive Director of Regulatory Affairs, you will be responsible for the complete preparation and management of the publishing and submission of regulatory authorities in the EU. You will also organise and coordinate submissions in line with internal and external SOPs and provide advice and guidance to internal colleagues on submission issues. In addition, as part of your role as Associate Director, you will assist colleagues in the US with posting clinical trial information on the internet.
Main Responsibilities:
Preparation and management of the publishing, compilation and assembly of documents for various submissions.
Advise on submission strategy and take part in regular meetings.
Provide training to personnel and consultants on regulatory submission and review activities.
Assist in the writing of the SOPs.
Assist the US regulatory operations team as needed.
Take part in regulatory department meetings to transmit knowledge and discuss issues that need Reg Ops attention.
Person Specification:
To be considered for this Associate Director (Regulatory Operations) position, you must have the following qualifications and experience:
Hands on experience with publishing/submissions in the pharmaceutical industry.
Strong working knowledge of EU regulations.
Electronic publishing experience – CoreDossier, Documentum, etc.
Self sufficient.
Excellent leadership skills.
Good interpersonal skills.
Apply Now:
For more information, or to apply for this Associate Director (Regulatory Operations) role, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.
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