Certificate in Signal Detection and Data Mining

A Safety Signal refers to information on a new or known adverse effect that may be caused by a medicine and is typically generated from more than a single report of a suspected side effect. It’s important to note that a Signal does not indicate a direct causal relationship between a side effect and a medicine, but is essentially only a hypothesis that, together with data and arguments, justifies the need for further assessment. The information in a signal can be new or additional and can be about both the adverse and beneficial effects of an intervention. It can also inform about an already-known association between a medicine and an adverse drug effect.

Signal Detection and Data Mining involves using advanced computational techniques to extract patterns and insights from large datasets. Data mining techniques can significantly enhance signal detection in several ways. Data mining in pharmacovigilance utilizes advanced analytical techniques to extract meaningful patterns from large datasets, enabling the early detection of potential safety signals and improving the identification of adverse drug reactions (ADRs), ultimately enhancing patient safety and regulatory compliance. 

This programme targets the training needs of executives who are or will be involved in the implications of Signal Detection databases and suggesting a possible causal relationship between an adverse event and a drug. This certificate programme develops an understanding of the tools and sources for Signal Detection along with the Databases that support Signal Detection with the upfront of the current Regulatory framework involved with the Pharmacovigilance Systems. This programme will provide benefit in terms of: -

• Knowledge to assess the Possible Causal relationship between an adverse event and a drug
• Analysis of Risk measurement by the analysis of change in the frequency, severity, or specificity of a known adverse event, or the identification of a new adverse event, drug interaction, or a new population at risk
• Identification of a New Beneficial effect of a drug
• Addressing the potential drug-related problems after a drug is marketed, which is crucial for patient safety, Assessing Signal Management
• Ensuring the Analysis of Benefit-Risk ratio of a drug
• Data Mining- Statistical Techniques and Methodologies of Signal Detection

Programme Modules

Module 1: Introduction to Signal Detection and UMC Causality Assessment Scales

Module 2: Implications of Signal Detection

Module 3: Databases, tools and sources that support Signal Detection

Module 4: Traditional Methods of Signal Detection, Current Signal Detection Strategies

Module 5: Regulatory Considerations in Signal Detection

Module 6: Data Mining- Statistical Techniques and Methodologies

Module 7: Signal Management, Prioritization and Evaluation

Module 8: Quality Assurance for the Signal Detection

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

The duration to complete this programme is 3 months.

Programme Mode

Registrations are currently open for regular and online both modes.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants
• All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for online examination. After successful completion the participants will be awarded Certificate in Signal Detection and Data Mining by IGMPI. For all the above-mentioned modules elaborate programme material would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with leading biotechnology companies like Zydus Cadila, Veeda Clinical Research, Arkus Research, Ethicare CRO, Apotex, Alembic, Colgate Palmolive, Cadence Life Sciences, Sun Pharma, Siroclina Pharm, UCB, TCS, Cognizant, IQVIA, PVCON, Novartis, Dr. Reddy’s, Aurobindo, Hetero Drugs, MSN Labs, Mylan, Vizen Life Sciences, Sanofi/Shanta Biotech, Parexel, Mitocon Biopharma, ICON, Accenture, Rx MD, Take Solutions, TCS, Kinapse, MSD (Merck), I3 Global Drug Safety, GVK, WNS, Wipro, Pharmalex, Pharmxl, Jubilant Life Sciences, Sun Pharma, DDreg, Elite Safety, APC Pharma, Syneos Health, APCER Life Sciences, Kinapse, Lambda, Torrent Pharma, Otsuka Pharmaceuticals, Zydus Cadila, Veeda Clinical Research, Novartis, GlaxoSmithKline, Ranbaxy, Pfizer and Lupin.

The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Biotechnological, Pharmaceutical; Pharmacovigilance and Healthcare industries on regular basis.

Future Career Prospects

The objective of this program is to impart knowledge and practical understanding about the Signal Detection and Data Mining Systems in Pharmacovigilance. Professionals who are willing to have a successful career in Pharmacovigilance in emerging markets should attend this programme. This program is highly recommended for those who are aspiring to move into Pharmacovigilance Signal Detection Systems.

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Programme Fee Details

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free),  9 am to 5:30 pm IST-except on Central Government holidays.