#Pharmacovigilance (Oracle Argus Safety Database

[gratisol]

Clinical Research and Management Course In Hyderabad With Placement Assistance In Hyderabad.

Gratisol Labs is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer Clinical Research Training program. This Advance Certification Clinical Research course also covers Pharmacovigilance Training, Clinical Data Management training,SAS Training. Medical Writing training and Regulatory Affairs course. We offer clinical research Certification Program also offers Clinical research Job Opportunities as Clinical Research Associate and Clinical Trials Associate. For CRA Training program the candidate should have B.Pharmacy,M.Pharmacy,Life Sciences ,Microbiology,Biotechnology,Chemistry. BPT,BDS and BHMS Also eligible for Clinical Research training program. For B.Pharmacy and M.Pharmacy the pharmacovigilance course is best suitable course. The pharmacovigilance training in hyderabad at gratisol imparts both theoretical and Practical with hands on experience on Argus database and MedDRa Medical browsers thus the reason gratisol is considered as the best pharmacovigilance institutes in hyerabad within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates.

The Clincal Data Manamgent Training offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Application Training in Clinical Data Management course (Oracle Clinical, Oracle Inform/Central Designer), Pharmacovigilance (Oracle Argus Safety Database, Oracle AERS), CDISC SDTM & SAS to aspirants of Clinical Research Industry. We successfully help some of the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals.

The Pharmaceutical & Clinical Research Industry, worldwide is facing a huge shortage of trained manpower resources. With a View to fill this gap between the demand & supply of trained manpower and to help Pharmaceutical & Clinical Research industry to move on the fast track Gratisol Labs offers cutting-edge packaged and customized corporate training programs. In addition, Gratisol Labs has developed a tailored training division Gratisol Academy of Clinical Research to provide Training, Internships, & Educational programmes that are designed to develop careers for clinical research professionals in Clinical Data Management, Pharmacovigilance & SAS.

The focus of the lectures will be mainly on the following topics:

»   History and over view of pharmacovigilance

»   Introduction and responsibilities: USFDA, EMA and CDSCO

»   Pharmacovigilance in India

»   Clinical Development process

»   Different phases of clinical Trials

»   Adverse events and its types

»   Drug Safety in clinical trials and post marketed drugs

»   Different sources of Adverse events reporting

»   Different types of AE reporting Forms

»   Expedited reporting and its timelines

»   Different departments working on Pharmacovigilance

»   Roles and responsibilities of case receipt unit

»   Roles and responsibilities of Triage unit

»   Four factors for the reportable case

»   Seriousness criteria of adverse event

»   Expectedness or Listedness of adverse event

»   Causality assessment of the adverse event

»   Introduction to safety databases and different types

»   Importance and procedure of duplicate check

»   Case booking or initiation

»   Introduction to MedDRA and WHODD

»   Narrative writing

»   Case quality check, Medical review and its submission.

»   The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area

»   PSUR and its submission timelines

Practical Training will be also provided on Safety Database on the following topics:

»   Data Entry

»   Case Processing

»   MedDRA & WHODD coding

Gratisol Labs Advantages:

»   Oracle Argus Safety Database - Latest Production Version 7.0

»   4 months internship available after training

»   Own CRO live projects

»   Highest Placement record across all training institutes

»   Industry SOPs based training

»   Trainers with minimum 5 years experience

»   24 hours access to application lab

Course Timings

10:00-11:00 Am

Trainer Information

Industry Experts from Novartis, Parexel, TechMahindra, Infosys, HCL, MakroCare, Aurobindo Pharma, Natco Pharma, Dr Reddys will deliver the classes

Eligibility

Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master�s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs.

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Gratisol Also Offers the Following Courses:

Pg Diploma in Clincal Research

Computer System Valdiation Course

Advance Certification in Clinical Research and Pharmacovigilance

Clincal Research and Clinical Data Management Certification Course

Clinical Research Associate training

Training Location (Venue)

Gratisol Labs,

Vasavi MPM,8th Floor,905,

Ameerpet,Above west side showroom,

Hyderabad,Telangana - 500073

Contact Information

Call : 9705790302,8885198390

Website: https://gratisol.com/

[sollers-college]

Pharmacovigilance is the heartbeat of pharmaceutical production. Do you think there’s something more significant than the safety of a patient?

Unique program designed for professionals aspiring to make a career in Drug Safety using the in-demand, industry-based Oracle Argus Safety Database Software.

[techsolcorpmarketing-blog]

Oracle Empirica - Oracle Argus Safety Database

Techsol in partnership with Oracle Health Sciences provide world’s leading Safety Data Management and Reporting System Argus Safety. We also offer Axway Interchange and Oracle B2B gateway to enable you on electronic secure file transfer and submission.

Techsol offer various professional services including implementation, validation, case migration, upgrade, E2B R2 R3 HL7 consulting and cloud hosting(med info cloud). Our team has expertise on Argus Safety, ArisG, AERS and various other market leading safety databases.

Argus Safety platform: Enables making faster, better safety decisions with scientific querying and analytics, improves quality and efficiency through safety integration and automation, enhance compliance with E2B exchange and periodic reporting and enables conducting global case processing that scales easily to millions of cases.

Axway Interchange: A high-performance, scalable B2B gateway used by various regulators themselves, designed for real-time communications using a wide range of B2B messaging protocols — such as EDIINT AS/2, ebXML ebMS, and OFTP

Techsol Services

Our Pharmacovigilance techno-functional consultants understand your business challenges and provide various expert services including:

Solution design activities including business/functional requirement analysis, solution strategy, solution design and selection

System integration services using accelerators to deliver implementation, validation, upgrade, project management, data/systems migration, end user training

Case data migration and qualification accelerators. Migration accelerators (ArisG to Argus, AERS to Argus etc.)

Fully managed regulatory compliant cloud hosting. Multi-tenant and Single tenant private cloud options. Implement Argus on Oracle cloud

Service desk and application support

Design and development of custom reports using OBIEE and other BI platforms, mobile apps etc.

All ourearly phase clinic automation services utilize our Optimized Global Service Delivery Model designed to make you fully compliant with regulatory requirements and industry standards.

[healthcarebiz]

Celltrion taps Oracle Health Sciences Safety Solutions to Help Bring Cost-Effective Life-Saving and Biosimilar Drugs to Market

Streamlines pharmacovigilance case management and safety reporting with Oracle Health Sciences Technology

REDWOOD SHORES, Calif., Sept. 26, 2017 /PRNewswire/ -- Oracle today announced that Celltrion (KOSDAQ: CELLTRION), a global leading biopharmaceutical company, has selected Oracle Health Sciences Argus and Oracle Health Sciences Empirica Signal to streamline its pharmacovigilance case management and patient safety initiatives – helping to bring more chronic disease and life-saving therapies to market more cost-effectively.

Driven by the cost saving potential of biosimilar drugs – an estimated $100 Billion in global healthcare spending cuts by the end of 2020* – there is an emergence of biosimilar drug manufacturers entering the market and regulatory bodies like the FDA are helping to accelerate getting these drugs to market. A key aspect in getting these treatments to market is safety and efficacy regulatory reporting, and Celltrion has turned to Oracle Health Sciences technology to help streamline the process.

"Since our founding in 2002, we have remained committed to making more advanced therapeutics available to everyone, and have turned to technology to help us achieve our goals. Oracle Health Sciences technology is supporting us in meeting today's regulatory requirements and will enable us to move and shift as the regulatory landscape evolves, so that we can bring more life-saving and treatments to market safely and cost-effectively," said Dr. Sang Joon Lee, vice president for Celltrion, Inc.  

In an effort to streamline its pharmacovigilance case management and reduce IT costs, Celltrion has selected Oracle Health Sciences Argus Enterprise Edition which provides a comprehensive platform that will enable the company to make faster and better safety decisions, optimize global compliance and integrate risk management into key processes. Oracle Health Sciences Empirica Signal delivers a dynamic, visual data-mining environment that will enable Celltrion to detect safety signals, uncover patterns and recognize trends in spontaneous adverse event reporting.

"It is great to see the biopharmaceutical market headed in new and innovative directions as we are seeing with the emergence of more biosimilar manufacturers. Oracle Health Sciences remains committed to evolving and innovating to continue meeting the needs of our existing and potential customers," said Steve Rosenberg, general manager, Oracle Health Sciences. "Celltrion is a glowing example of a biotech company that is innovating to help improve people's lives."

Additional Resources

Follow us on Twitter  Learn about Oracle Health Sciences Safety Solutions   *Source

About Oracle The Oracle Cloud offers complete SaaS application suites for ERP, HCM and CX, plus best-in-class database Platform as a Service (PaaS) and Infrastructure as a Service (IaaS) from data centers throughout the Americas, Europe and Asia. For more information about Oracle (NYSE:ORCL), please visit us at oracle.com.

About Celltrion, Inc. Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EMA approval for Inflectra® and Remsima®, respectively, which is the world's first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received EMA approval for Truxima™ (CT-P10, a proposed mAb biosimilar to Rituxan® (Rituximab)) in February 2017. For more information, visit www.celltion.com.

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Read this news on PR Newswire Asia website: Celltrion taps Oracle Health Sciences Safety Solutions to Help Bring Cost-Effective Life-Saving and Biosimilar Drugs to Market