Thursday, January 29, 2009

DIA’s 1st Workshop on Pre-market Evaluation of Quality and Bioavailability

DIA’s 1st Workshop on Pre-market Evaluation of Quality and Bioavailability

Place: Hyderabad, India
Date: 05/02/2009 - 06/02/2009
Organizer: Drug Information Association
Contact: Leena Amanna
Contact Email: Leena.Amanna@diaindia.org
Contact Tel: +91-22-6765-3227

Description:
This workshop will clarify the approval requirements for drugs developed in India for global markets. You will have the opportunity to participate in the exchange of alternative perspectives from industry, academia, and regulatory professionals.

Target Audience:

• Regulatory affairs
• Research and development
• Quality control
• Quality assurance
• Regulatory assessment
• Outsourcing management/Contract Research Organizations (CRO)
• Good Clinical Practices (GCP)
• Chemical Manufacturing & Controls (CMC)
• Product selection.

Wednesday, January 28, 2009

Advance Program in Clinical Trial, Research & Data Management Students Feedback – on their visit to NIMR

BII Institute had planned a 4 day educational visit to NIMR from 20th Jan’09 to 24th Jan’09, at Civil Lines. We got this golden opportunity to visit NIMR because of Dr.Kumud Sarin and Dr. Neena Valecha.

The visit to NIMR was very well planned. It was a very good opportunity for BII students to communicate with well experienced staff working under Dr. Neena Valecha. We are also thankful to Mrs. Beena Srivastava who took care of BII students, under the guidance of Dr. Neena and Mrs. Beena we got to know about the minute details of protocols, CRF’s and ethics committee.

We started our session by discussing phases of Clinical trials. We also discussed on other aspect of Clinical Trials. Mrs Beena showed us the protocols, different versions of protocols that involved multi as well as single centric studies. All the queries regarding the protocol were resolved by Mrs. Beena. They also showed us how amendments were made in protocols. We were made to read protocols and told to review the minute details about the protocol. They also discussed about the ICD. Mrs. Beena shared her experiences of malarial research. She also explained about the importance of GCP during a Clinical Trial.

In the next session, our queries on clinical research were resolved by Mrs. Beena. On the second day we started discussion on ethics committee and regulatory body. She discussed with us about the procedures involved in meeting conducted by ethics committee, e.g.: the minutes, the agenda, the proposals, EC approval letters, protocol deviation / violation, SAE’s report. She also showed us the IND application and the requirements of document related to approval of protocol along with Investigators Brochure, CRF’s, DCF, CRF books.

Students who have participated in the visit are Meeta, Anika, Divya, Nidhi, Shilpi, Rakhi, Imran, Aarti, Prashant, Preeti.

Overall, it was a very refreshing, gainful experience in terms of education and practical aspects. It builds in us the confidence that we can achieve heights in the filed of Clinical Research.

We would like to thank Dr.Kumud Sarin, Dr. Neena Valecha and Mrs. Beena Srivastava for allowing us to visit NIMR and providing us with this opportunity. We are also thankful to them for sharing their valuable time and experiences.

From: BII Students for the Advance Program in Clinical Trial, Research & Data Management

Job Openings in Walter Bushnell

Applications are invited for Ph.D. Program at Institute of Bioinformatics

Applications are invited from motivated candidates for positions of Junior Research Fellows from qualified postgraduates in Life Sciences/Bioinformatics with a strong knowledge in programming for our ongoing research activities (see website for details). Selected candidates will be automatically enrolled in Ph.D. Programs. Stipends will be given as per the CSIR-UGC guidelines.

Essential Qualifications:

a) Should have experience working in C/PERL/Python, HTML, and MySQL. Experience in content development and content management systems will be preferred.

b) Experience in molecular biology, genetics/genomics, biochemistry or bioinformatics is desirable.

How to apply:

Application with detailed curriculum vitae (MS word format) and two letters of references (PDF format) may be mailed to careers@ibioinformatics.org with subject as "Application for the post of JRF/Programmer". Paper based applications will not be accepted. Short listed candidates will be called for an interview.

For further information, visit our website: http://www.ibioinformatics.org/

Or contact us at:

Institute of Bioinformatics

Discoverer, 7th floor, International Technology Park, Whitefield,

Bangalore 560066, India.

Phone: (+91) 80 28416140, Fax: (+91) 80 28416132

Friday, January 23, 2009

Bangalore Bio 2009

Bangalore Bio 2009 the flagship Biotechnology Event in India, follows after the tremendous success of Bangalore Bio 2008 which witnessed the participation of over 85 International and National speakers, over 700 delegates from the industry, R&D, policy makers and academia, over 10000 visitors, 150 leading global & Indian exhibitors.

Event Details:

Date: 18-20 June, 2009
venue: Bangalore International Exhibition Centre (BIEC)

Event Highlights

International Conference on Biotechnology
Technical Sessions (New)
International Trade Show (Biotech Expo)
BioPartnering (New)
B2B Meetings
RICH (Research Industry Collaboration Hub) (New)
CEO Conclave
Agribiotech Day
Poster Session
Bio Excellence Awards

Regulatory Professionals Can't Be In Isolation

Facing downturn into markets forced many to change and switch their profiles in a short span of time fearing job lossess.Numerous areas are affected leaving behind none.Number of working professionals,regular and students pursuing through distance or open learning have experienced and confronted the consequences of downturn market. No matter in which particular area,they are working or pursuing academic qualification,are influenced by recession.Now the professionals are heading towards areas which are least affected or even not to get secured future.

Major areas of concern such as Pharma regulatory affairs and pharma good manufacturing practices are one of the areas in pharma domains which are least affected and moreover these areas are experiencing dearth of professionals who are well versed with sound knowledge background. Professionals are trying hard to switch over to another areas of interest which are far away from recession.

The profiles in these particular domains are more concerned with carrying out the ethical regulation for products,samples,devices or even molecules so that their efficacy,strength,purity,safety can prove the products to be safe following their postmarket surveillance.Profile itself reveals the importance and majorly the responsibilities for creating emergencies for daily in house activities.

Numerous options are available in this particular domain.Domain specific areas such as pharma regulatory affairs is not only concerned with manufacturing or CROs but also with medical devices, biotech and moreover with government and non government agencies.Professionals who are still into academic qualification have started opting for distance or certificate,regular qualification in the areas of pharma regulatory affairs and GMP.














Pharmacology & Toxicology Guidelines for Pharmaceutical industry

Monday, January 19, 2009

Huge Affair:MNCs Expanding Regulatory Affairs Group

Numerous Lifesciences,Biotechnology and Pharma majors have already expanded their domain in regulatory affairs.The expansion is in full swing and majorly providing services in regulatory affairs domain to Pharma and BioPharma clients followed by creating and implementing development plans to meet all the regulatory requirements concerning approval of new drugs,it’s safety and providing support for marketed products and lifecycle management.

The regulatory affairs cell is responsible for providing Significant support to the products from pre development stage to post marketing stage in therapeutic areas such as CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular disorders. Moreover the companies are giving break to the professionals with world class experience and expertise in navigating through the drug development process with the national and international drug regulatory authorities. Thus making professionals capable to perform and excel with specialized regulatory knowledge in areas like health outcomes and post-approval research to provide clients unique regulatory insight in both the pre- and post-approval environment.

These companies are offering numerous services to their life sciences clients. The regulatory affairs professionals involved will conduct global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents.

Many of the MNCs are trying hard to curtail time and making the procedures smoother and easier by employing Regulatory Prep Services where the procedures for chemistry, manufacturing and controls documents (CMC) converted in the Common Technical Documents (CTD) format. New services helps provide briefing of procedures throughout formulation and process development in the common format established by the International Commission on Harmonization for submitting NDAs to the FDA and regulatory agencies in the respective countries







Clinical Trials in Asia Summit 2009

Clinical Trials in Asia Summit 2009
Determining the prospective strategies for Implementing Clinical trials in India & South Asia - Today's Hottest Market
18th - 20th February 2009, New Delhi, India

Clinical Trials Summit 2009 will discuss the on-going pressing concerns faced in clinical trials operations, addressing the risks, timeline and budget constraint, whilst effectively tackling key challenges in overcoming trials agreement and site contract negotiation hurdles.

Who should attend?
From pharmaceutical, biotech and CRO’s: Directors and Heads of:
• Clinical Research & Development
• Clinical Research Services
• Clinical Operations
• Clinical Data Management
• Clinical IT
• Clinical Trials
• Medical Affairs
• Regulatory Affairs
• Compliance
• Quality Control/Assurance/GCP
• Clinical Study Design
• Safety Surveillance
• Subject Recruitment
• E-Clinical Systems

To Register Visit: www.visiongain.com or
Call: 044 - 2073366100

Thursday, January 15, 2009

Bioinformatics Institute of India collaborates with Banasthali University for Gyan Ganga e-learning portal

Banasthali University has launched its e-learning “Gyan Ganga” Online portal in technical collaboration with BII. The online portal was launched in grand style on 23rd Nov’ 08 at University campus and will offer many Certificate courses in Life Sciences domain.

BII is already a premiere institution offering various distance, classroom, online programs and trainings in the emerging domains of Life sciences since past 7 years. This collaboration would now bring a new revolution as the students are now just a click away from online education in the emerging areas of life sciences.

Dr.Kumud Sarin, Sr.Program Director - BII was also one of the distinguished invitee on the occasion of launch of “Gyan Ganga” Portal. She detailed the function by presenting the salient features of the online content developed by BII in the field of Bioinformatics, Clinical trials, Pharma Regulatory affairs and Cheminformatics..

The following Certificate Courses are launched initially by BII and Banasthali:

• Certificate course in Bioinformatics
• Certificate Course in Clinical Trials
• Certificate Course in Pharma Regulatory Affairs
• Certificate Course in Cheminformatics

The courses are launched on nominal fees and have online student support, registration, course material and guidance. The portal can be accessed by visiting http://www.bansthali.org

For further details and enquiries regarding the collaboration and courses that are launched kindly contact:

Bioinformatics Institute of India
C-56 A/28, Sector – 62
Noida – 201301, U.P
Tel: 0120-4320801 / 02
Mobile: 9818473366, 9810535368
E-mail : info@bii.in
Web : www.bii.in

Monday, January 12, 2009

Optra systems joins Microsoft in its BIO-IT alliances initiative for life science image informatics

Optra system a leading life science and healthcare IT consulting company announced its joining the Microsoft BioIT alliances.
“We are delighted to welcome Optra system in to the BioIT alliances,” said Dr. Rudy Potenzone, Director of the alliance and Worldwide Pharmaceutical industry technology Strategies. “Optra system expertise in Life science and Healthcare Image Informatics space and a range of solutions for preclinical and clinical imaging adds a new perspective to the BioIT Alliance.
Abhi Gopalap, President and CEO of Optra System said “We are pleased to be a member of the Microsoft BioIT Alliance, we look forward to work closely with Microsoft and the other Alliance members. OPTRA with its array of solutions and offerings would enable the alliance members make more effective use of technology for research and development and advancing new products.” Optra systems has been a key partner for many life science and healthcare companies for developing complete workflow management including Image acquisition, storage, processing, analyzing and reporting. OPTRA has a vast experience and is supporting renowned academic institutions to speed up their research in Bioinformatics, Systems Biology, and Translational Medicine. Many pharmaceutical and Biotech companies rely on Optra for their needs like system integration, enterprise and business intelligence, data integration management, etc. Optra system is also partnering with microscopy and instrumentation companies to develop new products and solutions.
The Alliance brings together pharmaceutical, biotechnology, hardware, and software industries to explore new ways to share complex biomedical data and collaborate among multi-disciplinary teams to expedite discovery in the life sciences. It also enables the members to identify new technologies to over come the challenges faced by life science companies like data integration, collaboration, and knowledge management that cannot be solved by any organization alone.
Source: Life sciences Industry News

Flourishing Third Party Regulatory Business

Business is booming for Third party regulatory compliance and quality assurance professionals/vendors.Moreover they are in high demand for regulatory related activities performed in Medical device industry,Pharmaceutical industry,Biotech industry,CROs.As markets are facing cut throat competition,less time to market is most important..Investors are eager to see streamlined, mistake-free production with a minimum amount of rework, which means quality is a high-level concern.Globalization leads to increased outsourcing of manufacturing of products and components overseas where different sets of rules and regulation could impact outcomes.Non compliance of medical devices and various pharmaceutical products leads to charges of fraud.Subsequently have made many medical devices and pharmaceutical companies aware of the importance and need for compliance majorly in their supply chain and offshore operations Medical device industries and pharmaceutical companies majorly outsourced their product compliance tasks to third party regulatory compliance professionals,the basic idea behind the compliance outsourcing is to make their products reach Indian and international markets without risk of non-compliance.FDA inspections have focused on supplier management; a majority of its warning letters cite companies for failing to adequately control products purchased from their suppliers Employing specialized third parties for regulatory compliance by medical device and pharmaceutical companies with specific domain regulatory expertise and well versed regulatory professionals again who excelled the particular regulatory domain can help companies successfully navigate this complexity Moreover the Indian government is introducing stringent rules and regulations,to heightened awareness within the device and product community for the importance of regulatory compliance and thus to safeguard the individual and national health Companies are hiring third party as they have potential to provide significantally tremendous value rather than performing in house regulatory activities Numerous companies pay in the range of $250,000-$300,000 to regulatory and quality control personnel for inhouse regulatory works.Instead same companies believes in paying third party consultant 20% of that amount to do the work

Friday, January 9, 2009

Dear admin;

since one month i am mailing for original certificates.  i hav called number of times. the response last time was u hav posted certificates through registered post on 23 rd december to me. till now i didnt receive anything. this is very bad on your part. do the needful ASAP. I hav cleared all papers in pharma regulatory affairs in april 2008.

with regards

RAMARAJU SRINIVASARAO
S07PRAF10094
INDUSTRIAL PROGRAMME IN PHARMA REGULATORY AFFAIRS

Biotech Proposals

Visit : http://www.dbtindia.gov.in/ or http://www.dbtindia.nic.in/

Source :The Economic Times

DBT invites proposals from Biotech companies/Entrepreneurs For Innovative,early stage of available innovative research leads in biotechnology.

Thursday, January 8, 2009

Career in Pharmacy

Source: HT Horizons

Jawaharlal Nehru Centre for Advanced Scientific Research

Source: The Times of India

analytica Anacon India 2009

analytica Anacon India is an Indian trade fair with conference with international character designed to take exhibitors to new-developping marketplaces of significant interest. The concept has been transferred from the world- leading trade fair analytica in Munich which guarantees a high participation of international exhibitors and market leaders.

This year it will be held for the second time in Hyderabad, the home of India's biochemical and pharmaceutical industry.

Date: Sept 29 - Oct 01
venue: HITEX EXHIBITION CENTRE
HYDERABAD,INDIA
Opening Hours: 10.00 - 18.00
Entrance: The entrance is free upon registration, for trade visitors only.

Exhibition sectors:
- Analysis
- Measuring and teting / Quality Control
- Laboratory Technology
- Life Sciences and Biotechnology
- Medicine and Diagnostics

Visitor target Groups:

analytica Anacon India addresses Indian users and decision makers of the following sectors
- Chemicals and petrochemicals industries
- Pharmaceuticals industry
- Medical and diagnostics industries
- Environmental protection
- Electronics and electrical engineering
- Industrial research and development
- Public-sector research and development
- Public authorities / public facilities / universities / research institutions


Contact:
For exhibitors from India:

Sonia Prashar
Indo-German Chamber of Commerce
German House 2, Nyaya Marg
Chanakyapuri, New Delhi
phone: (+91) 11 26878721 or 26111730
E-mail: soniaprashar(a)indo-german.com

Monday, January 5, 2009

Assignments Submission

Dear Sir/Madam,

I am enrolled in Spring 2008 Batch for Pharma Regulatory Affairs.
Can I know the extended date for assignments & Research study to be eligible for the April 2009 Examinations

Regards,
Deepak.P

A Comprehensive Biotech Growth


Souce:The Hindustan Times

One Day Workshop on Clinical Trials - 7th mar'09 by BII

Workshop Clinical Trials
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One day Workshop on Bioinformatics - 7th Feb'09 by BII

Workshop Bioinformatics
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