Short Courses on Biostatistics

The Department of Biostatistics at Christian Medical College

About Organization:

Christian Medical College is in internationally reputed medicalcollege and tertiary care hospital which was started in 1900 by Dr.lda Sophia Scudder, a young American missionary. Through its continued dedication to health care, education and research,CMC has earned a reputation as one of the leading institution in India. Today CMC offers 90 recognized training programs in medical, nursing and paramedical fields. It is 2234 bed multispecialty,tertiary care teaching hospital, which comprises of a vital, diverse and Inter-denominational community.

They are conducting Short courses on Biostatistics. For the details of forthcoming Events please see the below or you can visit their website:

Forthcoming Events:

Short courses

November

Instrument Development” and Qualitative Research Methods and Analysis
Nov 23-28, 2009
IndiaCLEN in collaboration with Samarth is commencing its workshops on social science on ""Instrument Development” and Qualitative Research Methods and Analysis" scheduled to be held from, 23rd - 28th November 2009 at the Biostatistics Resource and Training Centre (BRTC), Department of Biostatistics, Christian Medical College, Adjacent to College Chapel, Bagayam, Vellore 632 002. Those interested in participating can contact us through e-mail (admin@samarthngo.org) or call us at +91 44-45010070. Attached are the registration form and details regarding the workshops. To confirm your participation in the workshops, please send your fees with the registration form.
Download Application

December

Fundamentals of Biostatistics, Principles of Epidemiology & Statistical Package for Social Science (SPSS)
Nov 30-Dec 4, 2009
This course is intended to introduce principles of Biostatistics, in a simpler manner to researchers who are in need of statistical application. This course is also intended to introduce principles and illustrate some of the basic methods of epidemiologic research and to improve the participant’s ability to understand and use appropriate statistical procedures.
The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by November 20, 2009. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.
Download Application

Multilevel Modeling (MLM) and Generalized Estimating Equations (GEE)
Dec 7-11, 2009
This course is intended to introduce the concept of multilevel theories and statistical treatment of clustered data. This course enables the statisticians to understand the concepts of Multilevel Modeling (MLM), Generalized Estimating Equations (GEE) and their applications. This course also provides real time examples that will be analyzed using SAS software.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by November 20, 2009. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.
Download Application

SAS (Statistical Analysis System) Software Training
Dec 14-18, 2009
This course is intended to introduce the basic concepts to use SAS, in a simpler manner to researchers who are in need. This course is also planned to furnish the basic and some advanced statistical analyses techniques with real time datasets so as to improve the participant’s ability to understand and interpret the findings.
The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.
Note:The participants should have basic knowledge in computers.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by November 20, 2009. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Download Application

May/June

Fundamentals of Biostatistics, Principles of Epidemiology & Statistical Package for Social Science (SPSS)
May 24-28, 2010
This course is intended to introduce principles of Biostatistics, in a simpler manner to researchers who are in need of statistical application. This course is also intended to introduce principles and illustrate some of the basic methods of epidemiologic research and to improve the participant’s ability to understand and use appropriate statistical procedures.
The course is targeted towards researchers of varied profession such as medicine, public health, life science, social science, nursing, epidemiology, biostatistics etc.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by May 14, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Clinical Trial and Meta Analyses
May 30-June 4, 2010
The course intends to explain the design, analysis and interpretation of clinical trials and Meta Analyses. This course is targeted towards epidemiologists, biostatisticians, demographers and other researchers.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by May 14, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

Multiple Linear Regression, Logistic Regression & Survival Analysis
June 7-11, 2010
This course is intended to improve participant’s ability to conduct regression analyses and study the relationship between response variable and multiple predictor variables. This course is also intended to sharpen the skills of analyzing binary outcome data and interpreting regression coefficients.
This course is targeted towards epidemiologist, biostatisticians, demographers and other medical researchers.
Venue: The course will be held at the Biostatistics Resource and Training Center (BRTC), Dept. of Biostatistics, Christian Medical College, Bagayam, Vellore 632 002.
Course Fee & Accommodation: Nominally fixed at Rs 3,500/- per course. If more than one course is opted then Rs. 3,000/- per course will be charged, however the course fee for “SAS” course is fixed at Rs. 5,000/-.
Participants will have to bear their own expenses for travel, boarding and lodging. The Organizers will give lunch and snacks. However the organizers may arrange accommodation on request.
Course Fee should be paid in full by May 14, 2010. Payment can be made by Demand Draft in favor of “Christian Medical College Vellore Association Account”, payable at Vellore.
Note: After Registration if cancelled the course fee will not be refunded
The number of participants for each course is limited to 30 and admission will be purely on first come first served basis.

SAS (Statistical Analysis System) Software Training
June 14-18, 2010

Source:
http://www.cmc-biostatistics.ac.in/news.html

FDA Releases Draft Guidance for REMS

Risk Evaluation and Mitigation Strategies (REMS)

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009. The document describes the format and content of a proposed REMS, including supporting documentation, the content of assessments and proposed modifications of an approved REMS, which identifiers should be used on REMS documents, and how to communicate with FDA about a REMS. The guidance also provides an example of what an approved REMS might look like.

“With this new guidance, manufacturers will have a useful blueprint for how to develop these important safety strategies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

According to the draft guidance, a proposed REMS submission to FDA should include a proposed REMS, which concisely describes the proposed goals and elements of the REMS, and a REMS supporting document that provides additional information such as a thorough explanation of the rationale for, and supporting information about, the content of the proposed REMS. All proposed materials that are included in the REMS (e.g., proposed communication and education materials, Medication Guide, elements to assure safe use, patient package insert, enrollment forms, and prescriber and patient agreements) should be appended to the proposed REMS. A template for the proposed REMS is available on FDA’s website.

The REMS supporting document should thoroughly explain the rationale for and supporting information about the content of the proposed REMS, according to the draft guidance. The REMS supporting document should describe how and when each REMS element will be implemented and specify the rationale for the timelines and milestones. If any REMS activity will not be implemented at the time of REMS approval, the REMS supporting document should describe the reason for the implementation schedule. “For example, the document should address the rationale for whether a communication plan would be implemented before, or concurrently with, other elements,” the draft guidance says. A template for the REMS supporting document can also be found on FDA’s website.

In addition, the draft guidance describes REMS policies for certain regulatory situations. The draft lists FDA websites where documents about approved REMS will be posted. The FDA Amendments Act of 2007 granted FDA the authority to require the submission and implementation of a REMS if the agency determines that it is necessary to ensure that a drug’s benefits outweigh its risks. Future draft guidances will address additional REMS topics, according to an agency press release.

The following links are for the guidelines:

1.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
2.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm

Source: Pharmtech.findpharma.com, USFDA Site

GUIDELINES FOR STANDARD OPERATING PROCEDURES

for Good Statistical Practice in Clinical Research

Written by: PSI Professional Standards Working Party


INTRODUCTION

Professional codes of conduct for statisticians, such as those published by the Royal Statistical Society, stress general principles including the need for professional integrity, a primary concern for the public interest and the preservation of professional standards. However, there is a need for more detailed guidance in specific disciplines. Therefore, the PSI “Professional Standards Working Party” set out to provide guidance for the preparation of Standard Operating Procedures (SOPs) for Good Statistical Practice in clinical research.

The development of Guidelines for Standard Operating Procedures (GSOPs) appeared to be a natural step in the process of encouraging and publicising Good Statistical Practice in the analysis and reporting of clinical trial data. In preparing these GSOPs, the objectives of PSI are:

• to ensure that statisticians in the pharmaceutical industry are aware of the principles contained in published codes of conduct
• to provide guidance to encourage adherence to these principles in the application of statistics to clinical trials
• to publicise the principles of Good Statistical Practice for clinical research to other professionals, internal and external to the pharmaceutical industry
• to provide guidance in the preparation of SOPs to ensure compliance with the requirements of international Good Clinical Practice so as to satisfy regulatory requirements with respect to the collection, processing, analysis and reporting of clinical trial data.

The many varied roles statisticians fulfil within the pharmaceutical industry and related organisations (e.g. academic institutions and Contract Research Organisations (CROs)) preclude writing a definitive set of SOPs for all PSI members. Hence the decision was taken to develop GSOPs which would give detailed statements of the principles of Good Statistical Practice within the context of clinical research (thus building on the existing codes of conduct), but which would require that statisticians develop the guidelines into SOPs specific to their own organisations. Conversion of these GSOPs into SOPs appropriate for a specific organisation requires expertise. Care should be taken that the level of responsibility given to statisticians is appropriate to the level and depth of statistical expertise within the organisation. The adaptation of the GSOPs into working SOPs should be carried out to reflect the structure and expertise of the organisation.

The GSOPs address the most common requirements of statisticians practising in the field of clinical research. The areas covered are not exhaustive. In some organisations it will be appropriate to combine some of the guidelines into one SOP or to divide other guidelines into several SOPs.

The manner in which procedures are implemented is as important as the procedures themselves if the procedures are to be effective within the structure of a particular organisation. SOPs which are properly implemented as part of an overall quality system not only improve the quality of the service or product but also improve the productivity and efficiency of the process. For example, good trial design and good case report form design can greatly improve the quality of the data collected in a clinical trial.

The PSI “Professional Standards Working Party” was set up in May 1990 and was responsible for developing 11 of the following GSOPs over a period of approximately 18 months. The development process included input from many members of PSI through written comments and workshop discussion sessions. The development process has continued since then with reviews and revisions of existing GSOPs, as well as the preparation of new GSOPs. This review process takes place over a two-yearly cycle, and is the responsibility of the PSI Public Affairs Sub-Committee.

The GSOPs and the Royal Statistical Society Code of Conduct are now augmented by other relevant documents such as the International Conference on Harmonisation (ICH) documents on Clinical Study Reports and Statistical Principles for Clinical Trials and the Association for Clinical Data Management (ACDM) Guidelines for Writing Standard Operating Procedures.

For detailed of this guideline please see the below source for more details

Source:

http://www.psiweb.org/docs/gsop.pdf and

http://www.uk-legislation.hmso.gov.uk/si/si2004/20041031.htm

SAS® Product Drug Development Used in Healthcare

Drug Discovery and Development with SAS®

SAS provides a centralized, integrated solution for managing, analyzing, reporting and reviewing clinical research information. This solution enables life sciences organizations to make informed business decisions with confidence, to assess the safety and efficacy of research compounds more effectively, to collaborate across trials, phases and therapeutic areas successfully, and ultimately get better products to market faster.

Available Drug Discovery and Development Solutions from SAS:

SAS Drug Development provides an analysis and reporting solution that enables global collaboration with complete compliance and control. SAS OnDemand: Drug Development offers small and midsize businesses a centralized, controlled, Web-based solution for efficiently developing, executing and managing the transformation, analysis and submission of clinical research data.

SAS® Drug Development:

SAS Drug Development enables the collation and sharing of clinical research data throughout the entire organization via a well-managed, controlled, centralized repository. This single version of the truth enables rapid, efficient sharing of resources, data and knowledge across trials, phases and therapeutic areas at all stages of the clinical R&D process.

Benefits:

A single version of the truth. SAS Drug Development delivers full data integration and standardization via a centralized information repository that gives researchers throughout the organization direct access to both the research content and embedded intelligence tools at all stages of the clinical R&D process.

Full compliance with industry standards. SAS Drug Development provides the ability to meet industry expectations for managing research information content in accordance with government regulations, including 21 CFR Part 11, good industry practices (GxP) and sound business practices.

Automated integrity, traceability and transparency. The degree of transparency and traceability of all data analysis activities provided by the solution ensures ongoing quality control and quality assurance, and makes it easy to confidently address inquiries from regulatory agencies. More confidence in research decisions. Researchers can easily review multiple data sources to analyze research across trials, phases and therapeutic areas. This comprehensive view makes it easier to make go/no-go research program decisions earlier in the process.

Shorter development cycles. With the ability to make more confident decisions and analyze data from a single repository, researchers can reduce the time spent searching for, gathering and aggregating data for analysis. The solution also helps streamline and automate research and analysis tasks.

Download the complete SAS Drug Development Fact Sheet

How SAS Is Different

• A standardized, centralized repository. SAS Drug Development integrates data from all relevant sources, stores all information related to a clinical research program, and brings this information together in a standardized, centralized repository.
• Streamlined processes. By providing immediate access and ongoing insight into project progress, SAS Drug Development gives organizations better control over the deployment of resources, as well as the streamlining of clinical R&D processes and tasks.
• Integrated SAS® program development and execution. An embedded program development environment provides the ability to easily develop SAS programs and macro libraries, review log files and test program functionality.
• A truly collaborative environment. Research scientists and less technical users have direct access to research data, statistical results and all other relevant clinical research content via a secure, user-friendly interface.
• Full compliance. SAS Drug Development was carefully designed to meet existing and emerging government regulations, including 21 CFR Part 11, as well as good industry practices and sound business methodologies.

Only SAS provides a secure, collaborative framework that puts controlled power into the hands of researchers who need it. The result is greater productivity and efficiency in these areas:

• Integration. Efficiently integrate and manage data from a wide range of sources – such as electronic data capture (EDC) systems, in-house clinical data management systems (CDMS), labs and contract research organizations (CROs) – while leveraging investments in existing systems and resources.
• Analysis and reporting. Accurately assess and report on study data in a timely manner. Efficiently generate presentation-ready statistical summaries of clinical trials data and easily share results with researchers or reviewers on demand.
• Discovery. Use your growing research information repository to rapidly investigate critical drug safety issues, pursue new marketing claims and explore potential product-line extensions.
• Regulatory compliance. Document research content via integrated processes that provide versioning, audit trails and electronic signatures, as well as fully describing the relationships between all process inputs, transformations, analyses and results.

Note: The matter has been taken from the SAS® Site

WinNonlin® 6.0

Phoenix™ WinNonlin® 6.0 — Next Generation of the Industry Standard for PK/PD Modeling and NCA

Phoenix WinNonlin improves scientific productivity during critical drug development tasks by providing a comprehensive analysis environment that implements efficient reusable workflows and high quality outputs while reducing barriers to learning and collaboration, enabling more impactful quantitative decision making.

Phoenix WinNonlin 6.0 offers the following benefits:

• Comprehensive Analysis Environment: Perform virtually all of the analyses for standard PK and PK/PD studies. MORE
• Efficient Workflow Management: Create, reuse, and share analyses as stored workflows. Easily process, visualize, and tabulate data while allowing the flexibility to edit in Excel. MORE
• High Quality Outputs: Generate high-quality graphs, tables, and figures allowing for integrated communication of analysis results. MORE
• Easy to Learn and Share: Minimize the amount of time spent learning the software and promote collaboration through easily transferable project files, workflows, and templates. MORE
• Enables Compliance: Provide technical controls for 21 CFR Part 11 compliance when used in conjunction with Pharsight Knowledgebase Server™. MORE

Phoenix™ WinNonlin® Features

Key features of Phoenix WinNonlin include the following:

• Comprehensive Analysis Environment

Perform noncompartmental analysis of both blood and urine data using methods for rich or sparse datasets in a single run.

Three methods of AUC calculation: linear trapezoidal, linear/log trapezoidal, and linear up/log down.

Descriptive statistics, including weighted descriptive statistics.

Units definition and conversions, including the ability to specify preferred output units, units for a dosing regimen, and unit conversions.

Powerful data management tools allow users to append worksheets, change properties and/or transform columns, add BQL Rules or map cross product worksheets, as well as filter, join, merge, pivot, rank, split, and stack data.

Toolbox functions for deconvolution, semicompartmental modeling, nonparametric superposition and crossover design.

Automatic determination of initial estimates.

Analysis using general linear modeling approaches, including bioequivalence tests as appropriate.

Built-in scripting language (Pharsight Modeling Language or PML).

• Efficient Workflow Management

Workflow management tools that enable users to create, reuse, and share models and projects.

More powerful data management tools. Excel compatible workbooks, including formulas, functions, data import/export, missing value codes, sort, transformations and worksheet merge.

Insert favorite workflow components and/or sub-workflows into larger workflow diagrams.
Easily map data inputs to multiple models.

• High Quality Outputs

Significantly improved, report-ready graphs, plots, tables and listings greatly reduce the reliance on external graphics software.

Easily insert bar, column, and box plots; histograms; XY, QQ plots, and/or scatter plot matrices into your workflows.

Easily change the formatting of any plot to suit reporting requirements.

One-click export of results, plots, and tables to Microsoft Excel® or Word®, SAS, graphic files, or text.

• Easy to Learn and Share

An intuitive user interface provides multiple click-paths to accomplish the same tasks, allowing users to use the software in ways that make suit their personal preferences.

All data, models, scripts, tables, BQL rules, documents, models, workflows, plots, graphs, and outputs are contained in one project file that can easily be shared.

Classroom and online training courses will be offered regularly to support new users.

• Enables Compliance

Every workflow object has a 'Verification' tab that explains whether the object executed properly and any errors that may have occurred.

Full integration with the Pharsight Knowledgebase Server™ (PKS™) data repository enabling all changes to projects to be logged in the PKS database

Validation can be speeded up significantly with the Phoenix Validation Suite™

Note: If anything needed please see the below link-

http://www.pharsight.com/products/prod_phoenix_winnonlin_feature.php

Shire selects SAS® Drug Development to Handle Clinical Trials Data

CARY, NC (Jun. 22, 2009) – SAS, the leader in business analytics, today announced that Shire, the global specialty biopharmaceutical company, has selected SAS® Drug Development as the platform for its clinical trials data.

“Shire is excited about our partnership with SAS, and we look forward to leveraging the SAS Drug Development platform to manage our clinical trial data,” said Nick Ronca, Associate Director Clinical R&D, Shire Pharmaceuticals.

SAS Drug Development is available as a standalone or hosted solution with access via a secure, thin client. A centralized repository allows life sciences firms to aggregate, analyze and review clinical trials data to determine safety and efficacy outcomes.

“Our approach at SAS allows our customers, like Shire, to be more focused and efficient in developing and delivering medicines to patients and their families around the world,” said Jason Burke, Global Director of Health and Life Sciences for SAS.

21 CFR and CDISC Compliant
SAS Drug Development allows rapid and reliable validation and implementation, eliminating strain on limited IT infrastructure and resources. The solution is compliant with global agency regulations, such as 21 CFR Part 11, which is often difficult to attain.

“Our hosted global environment contains a single view of the targeted clinical data in a secured and qualified environment so scientists, programmers and statisticians can view the most up-to-date, accurate information” said Burke.

SAS’ scalability and flexibility were features important to Shire, which has grown rapidly through acquisitions and mergers over its nearly twenty-five year history. Shire, which has a presence in 23 countries and markets medicines in more than 45 countries, needed a global solution for managing and processing its clinical trial data.

“Working in unison with SAS allows Shire to focus on meeting its mission, and investing in its product portfolio instead of developing a complex IT infrastructure to support clinical data,” said Burke.

SAS Implementation Team
Relying on the SAS Consulting Group that has successfully deployed SAS Drug Development in the past, Shire believes that the system will maximize the best practices of both Shire and SAS. SAS is demonstrating SAS Drug Development at the DIA 45th Annual Meeting in Booth 301.

About SAS SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions delivered within an integrated framework, SAS helps customers at more than 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world The Power to Know® .

PG Diploma in Biostatistics

Madurai Kamaraj University - Directorate of Distance Education

Madurai Kamaraj University is a Statutory University, established in 1966 by Govt. of Tamilnadu. It is recognized and funded by UGC and is a member of Association of Indian Universities. It has been reaccredited by NAAC with grade A.The Directorate of Distance Education of this university was established in 1971 and has a student strength of about 1.20 lakhs. There are 38 Spot Admission Centres and 85 Study Centres outside Tamilnadu across the country and 12 Study Centres outside the country. Recently this University was accorded the status of "University with Potential for Excellence" - A status conferred by University Grants Commission so far on 9 such Universities in the Country. The home site for this is

http://www.mkudde.org/

Recognized by Distance Education Council (DEC), New Delhi Eligible for Central & State Govt. Employment

The following Link is for the different Post Graduate Diploma Courses

http://www.mkudde.org/courses_pgdip.php

Indian Institute of Public Health—Hyderabad, Summer Institution Program

Indian Institute of Public Health

A year long Post Graduate Diploma in Biostatistics and Data Management was launched in August, 2008 at IIPH-Hyderabad. This course was designed to equip students with modern tools of data management and applied biostatistics, in order to qualitatively enhance the skills of practicing biostatisticians and epidemiologists in the areas of medical research and public health. The target audience for this course includes public and private sector organizations, academicians and researchers in public health, medical colleges, hospitals, contract and clinical research organizations and pharmaceutical agencies, those engaged in national public health programmes initiated by the Government of India and research institutions.

Course
Post Graduate Diploma in Biostatistics and Data Management can be downloaded from below link

http://www.phfi.org/downloads/pdf/Post%20Graduate%20Diploma%20in%20Biostatistics%20and%20Data%20Management.pdf



Application Form- PGDBDM can be downloaded from below link

http://www.phfi.org/downloads/pdf/Application%20Form%20-%20PGDBDM.pdf



Poster - PGDPBDM can be downloaded from below link



http://www.phfi.org/downloads/pdf/Poster_Biostatistics.pdf





The Indian Institute of Public Health—Hyderabad, Summer Institution (June-July, 2009)details / Catalog/ are can be downloaded from the following Link:



http://www.phfi.org/downloads/pdf/IIPH-Hyderabad%20Summer%20Institue%20(June-July%202009)%20Course%20Catalog.pdf

US Department of Health and Human Services renews SAS contract

US Department of Health and Human Services renews SAS contract for three years
SAS® technology used throughout HHS for performance management, disease surveillance, fraud detection

CARY, NC (Apr. 06, 2009) – The US Department of Health and Human Services (HHS) has renewed an enterprisewide contract with SAS, the leader in business analytics , to help protect the health of all Americans and provide important human services. The agreement, covering business and analytics software, services and training over the next three years, extends a 28-year collaboration between SAS and HHS.

HHS uses SAS software extensively in mission-critical solutions by several agencies, including Centers for Disease Control and Prevention, National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services. SAS is used in numerous applications for disease surveillance, food and drug safety, Medicare fraud and abuse, and other enterprise performance management initiatives throughout HHS.

The agreement gives HHS wide access to a variety of SAS business intelligence and analytics solutions, including SAS Enterprise BI Server and SAS® Enterprise Miner™.
"We're excited to work with HHS to find ways that technology can help support the President’s drive towards personalized health care," said Kelly Collins, General Manager, SAS Federal. "With the growing adoption of electronic medical records, increased genetic testing and a stronger focus on outcomes-based medicine, analytics are moving to the forefront of health information technology."

Accessing information they need through self-service reporting and customized, easy-to-use Web interfaces, HHS employees can make mission-critical decisions more efficiently and with greater confidence. HHS can use SAS for performance management initiatives, such as monitoring key performance indicators and delivering measurable results to support accountability efforts, while ensuring a wide range of organizational goals are achieved.
Over three decades, SAS has provided innovative solutions specifically addressing the unique needs of the federal government. All 15 US federal departments use SAS’ analytic and predictive capabilities for such critical initiatives as performance, budgeting, workforce management, logistics, combating fraud and threat assessment.

Healthcare providers and health insurance companies use SAS to analyze patient diagnosis, claims and care data, along with organizational enrollment and provider data to meet a variety of organizational goals.

About SAS: SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions delivered within an integrated framework, SAS helps customers at more than 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world The Power to Know® .

Courtesy from: http://www.sas.com/news/preleases/HHSrenewal.html

Different sites of E-books

Hi,

The following are the different e-books sites which are very useful in this BA/BE field.

1. http://pharma-books.blogspot.com/

2. http://www.mininova.org/tor/1506538

3. http://rijuebookbiostatistics.blogspot.com/2008/06/biostatistics-ebooks-free-download.html

4. http://onbiostatistics.blogspot.com/

5. http://labclone.blogspot.com/2007/06/primer-of-biostatistics-e-book.html

6. http://realizationsinbiostatistics.blogspot.com/

Note: All these are all collections from other sites for better purpose i had shown those here.

Scaled Average Concept in Bioequivalence Studies

Hi,

The following links are very useful to estimate the Scaled Average Bioequivalence Study procedures. This is an Hot topic in all the regulatory bodies for Highly Variable drugs.

http://www.aapspharmaceutica.com/inside/focus_groups/bioequiv/imagespdfs/Endrenyi2007.pdf

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_4_files/frame.htm

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_5_files/frame.htm

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_2_files/frame.htm

http://www.fda.gov/cder/audiences/iact/forum/200804_chandaroy.pdf#page=13

http://www.springerlink.com/content/u503p62056413677/fulltext.pdf

Note: All these are all a collection from all other sites.