33rd Pharmacovigilance India 2023
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Speakers
MAYUR PARMAR
FDA
MAYUR PARMAR
FDA
MAYUR PARMAR, Deputy Collector, Prant Officer & SDM, Government of Gujarat, Drugs Inspector, FDA
GEETA S
Ipca Laboratories
GEETA S
Ipca Laboratories
GEETA SHANBHAG, Vice President - Pharmacovigilance & Medico - Regulatory Affairs, Ipca Laboratories
• Currently, Geeta Shanbhag is working as Vice President – Pharmacovigilance and Medico-regulatory affairs at Ipca Laboratories Ltd.
• A management post graduate with pharmacy background, she has around three decades of experience in pharmaceutical industry, inclusive of medico-marketing, regulatory affairs, clinical research, bioequivalence studies, pre-clinical studies and pharmacovigilance.
• She is a proactive team player with strong planning skills, critical/ analytical thinking, multitasking, problem solving, and team management skills.
• From past 14 years, she is involved in pharmacovigilance. She has been instrumental in setting up in house pharmacovigilance department in Ipca, which handles end to end pharmacovigilance on global scale.
• She has hands on experience on both Aris G and Argus database, data migration, case processing, medical writing in pharmacovigilance, audits and inspection. In fact, Ipca successfully cleared its first US FDA pharmacovigilance inspection in 2017.
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI, Director and Head - Clinical Study Unit, India & South East Asia, Sanofi
• Dr. Vaibhav Salvi is a physician by training with specialization in Electro-cardiology.
• He has more than fifteen years’ experience in clinical research and drug safety.
• His research work has been presented at national conferences (Cardiological society of India, Indian Society of Medical Statistics, The Chennai Paediatric Electrophysiology Symposium) and international conferences (Drug Information Association, Statisticians in Pharmaceutical Industry, International Congress on Electrocardiology).
• He has more than a dozen publications to his credit published in journals like British Journal of Pharmacology, Journal of Pharmacology, Journal of Electrocardiology and Diabetes Care to name a few.
ASHISH GAWDE
Bayer
ASHISH GAWDE
Bayer
ASHISH GAWDE, Country Medical Director, Bayer
Dr. Ashish Gawdeis working asCountry Medical Director at Bayer Indiasince 2012 and is responsible for the overall functioning of Medical Affairs, Pharmacovigilance, Medical Governance and Phase IV clinical trials. He is a board member for Bayer Foundation India (Bayer CSR). He also plays a key role in supportingthe Managing Director (CDH) in Public affairs and health policy related matters. He is part of the Bayer Leadership Team in India and Asia Pacific and is also an active member of Organization of Pharmaceutical Producers of India (OPPI) and Indian Society for Clinical Research (ISCR).
He comes with vast experience in the pharmaceutical and clinical research industry, joining BayerIndia as Senior Manager- Clinical Research, heading clinical operations for Bayer Schering Pharma in India. He soon took on the role of Local Head of Monitoring and Site Management- Asia Pacific (India, Taiwan, Philippines and Indonesia) and was also the acting local Head for China and Hong Kong for 6 months prior to his current role. Ashish has completed his MBBS and MD (Pharmacology) from Mumbai.
KABIL K
Fresenius Kabi
KABIL K
Fresenius Kabi
KABIL KALATHINGAL, Joint Director, Head of Vigilance Competence Center, Fresenius Kabi
I am a pharmacovigilance leader with 11+ years of experience. I have led teams involved in end-to-end PV activities including management of ICSRs, aggregate reports, risk management plans, signals, computer system validation activities for PV systems and quality assurance activities for PV.
SAKSHI S D
Johnson & Johnson
SAKSHI S D
Johnson & Johnson
SAKSHI SHRIVASTAVA DESAI, Associate Director International Pharmacovigilance Strategy Realization, Johnson & Johnson
• "Sakshi Desai, works as an associate director, International pharmacovigilance Strategy Realization at Johnson & Johnson. She brings with her 15 years of rich experience in the field of Pharmacovigilance, Medical Affairs, Medical Governance and Quality & Compliance with extensive experience working in a global, cross functional, multi matrix environment. Sakshi has worked with multinational companies like GSK, TCS, Covance and currently works in a PV strategy role. In her current role, she drives the implementation and delivery of key strategic roadmap and initiatives across the IPV organization with patient and drug safety as the central goal.
• A natural problem solver and six-sigma black belt holder, she can read and interpret complex compliance issues to make accurate operational decisions & implement the right solutions. Sakshi has been instrumental in building process & quality enhancement initiatives leading to implementation of an internal control framework in her previous roles. She has played a pivotal role in setting up a proactive quality culture in every organizations that she has been a part of.
• Sakshi’s vision is to build an end-to-end, future-ready, proactive PV working model that caters for the digital era and is not prone to disruptions caused by external factors.
• Apart from this, Sakshi is an empath who actively mentors and coaches underprivileged young boys and girls to make them aware of the opportunities available to them and help them build a bright future."
DILIP PAWAR
Unichem Laboratories
DILIP PAWAR
Unichem Laboratories
DILIP PAWAR, Head - Medical Affairs & Pharmacovigilance, Unichem Laboratories
SATISH SETHI
Glenmark
SATISH SETHI
Glenmark
SATISH SETHI, Head Global PV Operations & SERM Surveillance Operations, Glenmark
• Experienced pharmacovigilance expert with approximately 15 years of professional experience in the pharmaceutical industry. Expertise includes strategic development and operational proficiency in overseeing projects related to aggregate reports, Risk Management Plans (RMPs), signal detection, and case processing.
• Collaborated with top 5 leading pharmaceutical organizations while working at Quantum Solutions, Parexel, and TCS. Currently serving as Head of Global Pharmacovigilance Operations and Safety Surveillance at Glenmark Pharmaceuticals.
SONICA S B
Indegene
SONICA S B
Indegene
SONICA SACHDEVA BATRA, Associate VP, Enterprise Medical, Head - Regulatory Solutions, Indegene
BABITA KIRODIAN
Amgen
BABITA KIRODIAN
Amgen
BABITA KIRODIAN, Country Pharmacovigilance Lead, Amgen
• Dr. Babita Kirodian holds a Ph.D in Liposomal Drug Delivery System from Dept of Clinical Pharmacology, Seth GS Medical College & KEM hospital, Mumbai, under Dr.N.A.Kshirsagar.
• She has over 20 years of industry experience in MNCs like Amgen, Bristol Myers Squibb and Abbott.
• Currently, she is working as Global Safety Manager for Amgen India, responsible for India, Indonesia, Philippines and other SEA countries.
• She was instrumental in setting up the PV council within Indian Society for Clinical Research (ISCR).
• Currently she is the Co-Chair of ISCR PV council.
• Speaker at various national and international events.
• Faculty for PV course.
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Deepa is an Experienced Clinical Development and Drug Safety physician. She served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities. Currently she is the Chief Executive Officer of Clinexel Life Sciences Pvt Ltd.
CLINEXEL is an agile, customer focused full service, Clinical Research Organization, that provides clinical research, pharmacovigilance, regulatory, auditing and medical writing services to pharma, biotech and medical device companies. At CLINEXEL, our mission is to partner with early-stage pharma and biotech companies for fast and efficient clinical development of their innovations.
INDU NAMBIAR
Boehringer Ingelheim
INDU NAMBIAR
Boehringer Ingelheim
INDU NAMBIAR, Head Pharmacovigilance, Boehringer Ingelheim
• Indu Nambiar is a Home Science Graduate with Majors in Nutrition. She pursued her P. G Diploma in Dietetics, and is a registered Dietician and holds a MBA in Service Excellence from Welingar’s
• Started her career in the Pharmacovigilance field in 2006, when she joined Novartis India Ltd. as Executive – Drug safety & Epidemiology (DS&E) and has been associated with this field for the past 15 years and continues
• She is a life time member of Indian Society for Clinical Research (ISCR) and was instrumental in the formation of the PV working Group within ISCR in 2014. She was the Co-Chair for the PV council from its inception for 4 years (2015 – 2019)
• Is responsible for academic collaborations with major universities to co-ordinator, prepare the course, identify faculties and conduct such PV certification courses
• Has contributed by being on the Scientific and Organising committees for the PV symposiums conducted by PV Council ISCR and was honored by the Hall of Fame during the ISCR Annual conference held in Mar, 2021.
• She has been a resource person in several National and International Pharmacovigilance conferences including the PV symposiums conducted by PV Council of ISCR
• Supported the Company cross collaboration webinars conducted for PV awareness among HCPs by being in the core committee, preparing the initial contents for sharing, being the first speaker and then Chairperson for these monthly webinars conducted
• Has been awarded for her consistency in being compliant to the ever changing regulations and received accolades from her Global PV team for innovations within the function
GIRISH SANE
Macleods Pharmaceuticals
ANUJA JAWALE
Organon
ANUJA JAWALE
OrganonANUJA JAWALE, Associate Director - RA/PV Strategic Engagements & Vendor Management, Organon • A Homeopathic Physician by Qualification with a Post Graduate Diploma in Clinical Research. • Total of 14 years of experience in Pharmacovigilance. Over the 14 years she has been associated with companies like Sanofi Aventis Pvt. Ltd, Tata Consultancy Services, Lupin Ltd. And Abbott India Ltd. • Currently designated as Associate Director Regulatory Affairs/Pharmacovigilance Strategic Sourcing & Vendor Management team within Organon’s Research & Development team. • Strategic Thinker and Problem-Solving Abilities leading to success of many projects and streamlining processed. Major experience and skill set lies in strategizing and coordinating with cross functional teams. • In-depth experience in end-to-end Pharmacovigilance operations Global function as well as Affiliate experience is managing Pharmacovigilance for region and countries. • Regular faculty for training PvPI staff on various pharmacovigilance topics.
ROSHAN PAWAR
Alkem Laboratories
ROSHAN PAWAR
Alkem Laboratories
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
Currently working as DGM & Head Medical Affairs at Alkem. Have more than 11 years of experience in pharmaceutical industry in therapy areas like oncology, rheumatology, cardio-diabetes and osteoporosis. Handled clinical development as well as scientific marketing of many Biosimilars.
Before pharma industry, worked as Assistant Professor in Dept of Pharmacology, Seth GS Medical College and KEM Hospital Mumbai
NILAY MODI
Amneal Pharmaceuticals
NILAY MODI
Amneal Pharmaceuticals
NILAY MODI, Senior Manager - Pharmacovigilance, Amneal Pharmaceuticals
1. Completed M.B.B.S. from S.M.T. N.H.L. Municipal Medical College (Gujarat University)
2. Contractual Medical Officer & Clinical Research Associate at Veeda Clinical Research April 2009 - 2011 (24 months)
3. Conducting Clinical examination and monitoring Vitals for well being of subjects during the study.
4. Responsible for safety and well being of study subjects
5. Handling and Reporting of Adverse Events and Drug Reactions and Clinical Emergencies in coordination with Principal Investigator (PI).
Senior Manager and India PV Head in Amneal Pharmaceuticals from Sep-21
• QPPV for Tanzania and PVoI for India.
• Head of QPPV Office | Head of PV Excellence and Alliances| Head of affiliate operations| Head of PV Automation| Head for PV International Expansion and Strategy
• Working as Delivery Head for end-to-end PV operations (individual case processing, literature searches, Signal, Aggregate Reports) from India
• New SOP preparation or revision of old SOP/WI
• Manage daily workload for individual case processing, literature searches, Signal, Aggregate Reports and any other tasks relevant to the Pharmacovigilance Department.
• Management of Compliance with the Company Standard Operating Procedures and regulatory requirements.
• Receipt and evaluation of safety data exchange agreements for sharing and other obligations (as applicable).
VISHWAS SOVANI
Pharmawisdom
VISHWAS SOVANI
Pharmawisdom
VISHWAS SOVANI, Founder Director, Pharmawisdom
• Founder Director, Pharmawisdom, a consultancy that focuses on clinical research, training and pharmacovigilance coaching.
Qualification:
• MD (Pharmacology), Mumbai University.
• Diploma in Management, IIM Ahmedabad.
• Over 35 yrs in pharma industry in medical department,
• Responsible for Clinical research, regulatory & medicomarketing and pharmacovigilance in companies like Sarabhai, Cipla, FDC, Cyanamid/Wyeth, Organon, in local and regional roles
• Was also Head of Pharma delivery in TCS BPO
• Retired as India Head for Revogenex Inc.
Additional professional activities:
• Chairman of the Ethics Committee of the Kaushalya Medical Trust Hospital.
• Medical expert in Ethics Committee for Jaslok Hospital.
• Ex-Chairman of Institutional Review Board of Bombay College of Pharmacy, Mumbai.
• Ex Referee and examiner for M. Pharm. (Pharmacology) & Ph. D (Pharmacology) course of University of Mumbai.
Publications:
BOOKS: Updates in Ophthalmology as editor.
JOURNALS: Over 45 publications in various therapeutic areas.
CHETANRAJ B
Serum Institute of India
CHETANRAJ B
Serum Institute of India
CHETANRAJ BHAMARE, Dy. QPPV (Asst GM) - Clinical Research & PV, Serum Institute of India
Dr. Chetanraj G Bhamare, is a Clinical Pharmacologist with more than 13 years of experience in the field of clinical research and pharmacovigilance. He did his graduation as MBBS and post-graduation as MD in Clinical Pharmacology and Therapeutics from Govt. Medical College in Maharashtra, India. Currently he is working in the world’s largest manufacturer of vaccines, Serum Institute of India Pvt. Ltd. (SIIPL), Pune in the capacity of Safety Physician.
Since 2015, he is working with Serum Institute of India Pvt Ltd and is involved in end to end pharmacovigilance activities of all vaccines and biologicals as well as clinical development.
He has many national and international publications to add to his credit.
Affiliations/Membership:
• Member of Indian Society for Clinical Research (ISCR) Pharmacovigilance Council.
• Member of Developing Countries Vaccine Manufacturers Network (DCVMN) Pharmacovigilance Working Group.
• Life member of Indian Society of Rational Pharmacotherapeutics and Life member of Indian Pharmacological Society.
RAHUL SOMANI
Alkem Laboratories
RAHUL SOMANI
Alkem Laboratories
RAHUL SOMANI, Sr. General Manager-Medical Affairs & PV, Alkem Laboratories
NAVEEN C
Novartis
NAVEEN C
Novartis
NAVEEN CHHABRA, Global Medical Safety Physician, Novartis
Dr Naveen is a gold medalist physician with experience in end to end PV activities. His core expertise includes medical review of ICSR, literature review, signal management, aggregate reports and authoring of risk management plans. He has also experience of project management. Currently he is working as Medical safety lead in Novartis. Prior to joining Novartis, he has worked in various BPOs/CROs.
NITISH GOEL
Freyr Solutions
NITISH GOEL
Freyr Solutions
NITISH GOEL, AGM, Pharmacovigilance, Freyr Solutions
• Nitish Goel is currently the AGM, Pharmacovigilance at Freyr Solutions where he leads the Aggregate Reports and Risk Management practice. He is a physician by qualificationhaving over 11 years of experience in the Pharma Industry. He is based out of Chandigarh, India.
• Nitish began his PV journey serendipitously with Quantum Solutionsand has since had the opportunity to work with top global companies like Parexel and Tata Consultancy Services.
• During his tenure at both these organisations, he was involved in scientific and project management activities for individual case reports, aggregate reports, signal detection and risk management, and medical review.
• Nitish is passionate about strategic leadership and patient safety. He loves music, singing,traveling, and spending his free time enriching his general awareness.
“Ensuring safer drugs to market. Latest developments in PV & RMP”
Conference Schedule
Meet and to network with your conference colleagues.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
AUDITS & INSPECTIONS
09:30 – PV Audit & Inspection readiness: Important Aspects
• Global PV Inspection
• Local PV Inspections
• Internal QA Audits
• Self Audits & Inspections
JAMAL BAIG, Multi Country Safety Head, Sanofi
CHALLENGES & OPPORTUNITIES
10:00 – KEYNOTE PANEL DISCUSSION: New Era of PV: Future Challenges & Opportunities
• What comes next for the industry?
• Automating pharmacovigilance: Are we ready for the upcoming future?
• Outsourcing - Best Practices, Challenges and key consideration in choosing right vendor
• How global PV impacts day to day operations?
• Proper communication between - Sponsor – Site – CRO – Patients
• Best practices and lessons learnt from the pandemic
Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom
Panellists
VAIBHAV SALVI, Director and Head - Clinical Study Unit, India & South East Asia, Sanofi
ANUJA JAWALE, Associate Director, Strategic Engagement & Vendor Management, Organon
JAMAL BAIG, Multi Country Safety Head, Sanofi
BABITA KIRODIAN, Country Pharmacovigilance Lead, Amgen
SATISH SETHI, Head Global PV Operations & SERM Surveillance Operations, Glenmark
10:50 – Morning Coffee / Tea & Discussion
PATIENT SAFETY
11:20 – PANEL DISCUSSION: Patient Centricity - Prioritising patient in patient safety
• Driving patient centricity into your PV plans
• Patient Support Program in Pharmacovigilance
• A review of general issues and the specific challenges with patients
• Benefits and challenges of implementing RWD and RWE
• A practical approach to reshaping patient safety
• Next generation pharmacovigilance for enhanced patient safety
• What has this pandemic thought us towards patient safety
Moderator
DILIP PAWAR, Head - Medical Affairs & Pharmacovigilance, Unichem Laboratories
Panellists
ASHISH GAWDE, Country Medical Director, Bayer
SAKSHI SHRIVASTAVA DESAI, Associate Director International Pharmacovigilance Strategy Realization, Johnson & Johnson
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
INDU NAMBIAR, Head Pharmacovigilance, Boehringer Ingelheim
NIDHI VAISH DAS, Manager Drug Safety, Roche
IMPACT OF TECHNOLOGY
12:10 – AI in Pharmacovigilance
NILAY MODI, Senior Manager - Pharmacovigilance, Amneal Pharmaceuticals
12:40 – Networking luncheon
RISK MANAGEMENT
13:40 – PANEL DISCUSSION: Planning for Future - Risk management and strategies in PV
• Potential analyzing of safety and risk signals in PV
• Strategies to minimize the risk measures – what are the new developments?
• How the data analytics will make a better way to avoid risks?
• Risk Evaluation and Mitigation Strategies(REMS) – new challenges and chances
• Stakeholders in REMS – Communications must be improved
• Discussing about the strategies that support the PV from beginning to end
Moderator
ABHAY CHIMANKAR, Founder and Director, Rhyme Life Sciences
Panellists
MAYUR PARMAR, Deputy Collector, Prant Officer & SDM, Government of Gujarat, Drugs Inspector, FDA
SONICA SACHDEVA BATRA, Associate VP, Enterprise Medical, Head - Regulatory Solutions, Indegene
CHETANRAJ BHAMARE, Dy. QPPV (Asst GM) - Clinical Research & PV, Serum Institute of India
NITISH GOEL, AGM, Pharmacovigilance, Freyr Solutions
MARKET TRENDS
14:30 – Pharmacovigilance: Critique and Ways Forward
• The Evolving Role of Pharmacovigilance and Drug Safety
• Good Pharmacovigilance Practice: The Way Forward?
• Setting standards for proactive pharmacovigilance in India
ABHAY CHIMANKAR, Founder and Director, Rhyme Life Sciences
15:00 – Afternoon Tea / Coffee
SAFETY – SIGNAL DETECTION
15:30 – PANEL DISCUSSION: Quality, Safety & Signal Detection – Best practice
• Developing a global safety intelligence process
• Exploring patient support and marketing research programs from a safety perspective
• Statistical signal detection as a routine pharmacovigilance practice
• Implementing signal detection in RWD: the necessary steps.
• Moving towards a better future: bigger and better
• Lessons learned from covid-19 vaccine related to signal detection and evaluation
Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom
Panellists
KABIL KALATHINGAL, Joint Director, Head of Vigilance Competence Center, Fresenius Kabi
GIRISH SANE, Section Head PV, Macleods Pharmaceuticals
NAVEEN CHHABRA, Global Medical Safety Physician, Novartis
REGULATORY
16:10 – KEYNOTE PANEL DISCUSSION: Key regulatory updates that can impact the PV. Changes that can increase patient’s safety
• Pharmacovigilance regulations in India: A Step forward
• Current and future trends in PV regulations
• Balancing the critical elements of speed and safety
• Regulations on adverse events
• Guidelines for critical medicines
• Future Legislation: Pharmacovigilance Industry Vision
• Enhancing communication between regulators, regional authorities and patients
• What’s next? Ways to proceed forward.
Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
Panellists
RAMESH JAGANNATHAN, VP Clinical Research & Pharmacovigilance, Bharat Serums and Vaccines
GEETA SHANBHAG, Vice President - Pharmacovigilance & Medico-Regulatory Affairs, Ipca Laboratories
AMIT PANDEY, Executive Vice President & General Counsel, GSK
DEEPA ARORA, CEO, CLINEXCEL Life Sciences
RAHUL SOMANI, Sr. General Manager-Medical Affairs & PV, Alkem Laboratories
APARNA PRABHUNE, Assistant General Manager – Regulatory Affairs, Wockhardt
17:00 – Closing remarks and end of conference
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Sponsors & Partners
Rhyme Life Sciences
Rhyme Life Sciences Private Limited(RLS) is established in 2017 with the determination and commitment to offer the Pharmaceutical industry with the solutions which are innovative, and compliance driven thereby meeting the regulatory expectations. We committed to deliver accurate, timely and cost-effective services throughout the regulated markets. We are team comprising of experienced professional including physicians, pharmacists, life science graduates and post graduates. Team is well acquainted with the regulatory needs including but not limited to USFDA, EMA, TGA, CDSCO and others. We are assertive and confident to have 'know how' We are proud to highlight our expertise in handling USFDA and MHRA inspections.
Our services:
- Literature monitoring: Literature screening, Follow up of lit. reports, screening of non-valid articles, signal report based on non-valid articles
- Review of MLM source data, xml file(including acceptance and/or rejection)
- Case processing: Mailbox handling, book-in/log in, triage, data entry, quality review, medical review, case lock, case submission
- Aggregate report: PSUR(R1), PBRER (R2), PADER, India PBRER
- RMP: EU RMP, Non EU RMP
- Signal management: Including signal detection, signal evaluation, prioritising and drafting signal reports
- Setting up PV system- This include PV policy, SOP preparation, resource estimate, mailbox, internal communication, formation of safety review committee
- PSMF maintenance
- SDEA management
- HHE reports
- Third party audit
- Training to partners
- SPC/PIL comparison
- QPPV/local QPPV services
- Preparation of DSUR
- Consultation on MHRA, USFDA and other Regulatory Inspections. Rich experience in handling the inspections.
Clinevo Technologies
Clinevo Technologies is an IT firm that provides regulatory compliance and user-friendly cloud-based Software Solutions for Clinical Trials and Drug Safety / Pharmacovigilance to over 100+ Pharma/CROs.
Clinevo solutions, through their Integrated Clinical Trial Platforms, can help Clinical Trial companies conduct Decentralized Clinical Trials and Virtual Clinical Trials in a highly efficient manner.
Clinevo Cloud-based software and databases have been validated by several international authorities, including the USFDA, EMA, MHRA, Health Canada, DCGI, and others, and meet regulatory requirements such as HIPAA, ICH, GxP, 21 CFR Part 11, Annex 11, GDPR, and others.
Clinevo Technologies has a reputation for delivering solutions faster than majority of providers in this domain. Furthermore, they offer cost benefits that are unrivalled!
Some of their cloud-based Software Solutions are listed below:
Clinical Trial Systems
• Clinical Trial Management System (CTMS)
• Electronic Trial Master File (eTMF)
• Electronic Data Capture (EDC)
• eConsent
• ePRO/eCOA
• Randomization / IWRS
Drug Safety Systems
• Pharmacovigilance Database with AS2 Gateway
• Signal Detection
• Case Intake with MICC and Web Intake
Quality Management Systems
• Document Management System (DMS)
• QMS – CAPA, Change Control, Deviations and Audit Management
• Training Management / eLearn
Visit our website: www.clinevotech.com
ClinChoice
“ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. We do this by combining our 25 years of proven quality and results with expertise in 30+ therapeutic areas, a flexible approach, and dedicated teams who enable rapid startups and fast timelines.
Our commitment to the highest quality standards, flexibility, and timeline fulfillment has earned us and our clients consistent results. We provide services for the full development lifecycle to a wide range of clients, large and small, including six of the top 10 pharmaceutical companies, as well as small to midsize biotechnology companies. For us, our record of quality means consistency, accuracy and reliability. For you, it means a reliable partner and quality results.”
Visit our website: www.clinchoice.com
Vizen Life Sciences
Vizen Life Sciences is a global leader in providing comprehensive End-to-End Pharmacovigilance (PV) services. Our team of highly qualified and dedicated medical professionals including physicians and pharmacists will ensure full vigilance support for all types of products, from generics to innovators and advanced therapies. We offer a variety of services, including medical information call centre, ICSR processing and reporting, global Medical Literature Monitoring, Aggregate Report Writing, Risk Management Plan, Signal Detection, safety data exchange agreements, data migration of legacy data activity, EU and Australian QPPV services.
What sets us apart from other PV service providers is our ability to offer complete end-to-end cost-effective PV services along with safety databases, MedDRA, WHODrug, and Eudravigilance registration, all on a single platform. This allows for seamless integration of PV processes.
Our pharmaceutical clients have benefited from our cost-effective and high-quality pharmacovigilance services, which are delivered with exceptional customer satisfaction and compliance. Additionally, we have developed an in-house automation tool to perform daily literature Articles in different databases across therapeutic areas within minutes while completely digitalizing our Quality Management Systems.
At Vizen Life Sciences, we prioritize quality-driven and cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety. We have strategic locations in India and European global hubs, which allows us to offer our clients extensive support and regulatory compliance, including GMP and GCP audits and certifications, as well as regulatory dossier preparations.
Contact us today to learn more about how we can support your global pharmacovigilance needs.
Visit our website: https://vizenlifesciences.com/
CognifAI Solutions
CognifAI is an Generative AI startup dedicated to connecting human behaviors, AI technologies and growth opportunities. Our mission is to revolutionize how businesses work by providing customized AI solutions that help businesses make smarter decisions and deploy their resources more effectively.
CoVigilAI, a product of CognifAI is an innovative Generative AI based solution that harnesses the power of Artificial Intelligence (AI) & GPT technology to revolutionize the field of Pharmacovigilance. In this evolving realm, AI plays a pivotal role in transforming traditional practices. AI algorithms excel in analyzing vast amounts of data swiftly and accurately, enabling quicker identification of potential safety concerns and complex patterns that may be challenging for humans to discern. By automating routine tasks such as data sorting and signal detection, CoVigilAI frees up experts to focus on more nuanced decision-making.
Our AI-enabled pharmacovigilance solution employs advanced algorithms and data analytics to proactively detect and manage adverse drug events, ensuring patient safety and regulatory compliance in real time
Key Benefits of CoVigilAI:
- Implementing automated literature screening to reclaim up to 70% of the time typically allocated to this task.
- Establishing a trackable workflow for confidently managing Medical Literature Monitoring (MLM).
- Early Signal Detection: CoVigilAI employs AI to identify potential safety signals at an early stage, facilitating faster responses and risk mitigation.
- Enhanced Accuracy: AI algorithms reduce the risk of human error, resulting in more reliable analysis and reporting.
- Efficient Workflows: Automation of repetitive tasks boosts efficiency within Pharma Pharmacovigilance teams, allowing them to allocate more time to strategic thinking and collaboration.
CoVigilAI encourages professionals in the field of Pharma Pharmacovigilance to embrace AI tools, offering them a unique opportunity to elevate their ability to identify emerging safety trends and provide valuable insights for shaping regulatory decisions. It calls for collaboration in shaping the future of patient safety and healthcare excellence through the transformative power of AI in Pharma Pharmacovigilance.
CognifAI has also products like AccuLitAI - AI based Automatic Literature Validation and Digital Human as Digital avatar for enterprise influencer, marketing officer and Safety officer.
Visit our website: www.cognifai.in
Precise Analytics Lab
Leading Pharmaceutical, Water and Food Research and analysis organization in India, known as Precise Analytics Lab. With our unwavering commitment to excellence, we have earned national accreditation and approvals from the esteemed Government of India. Our dedication to delivering superior services and accurate results sets us apart as a premium provider in the industry.
FDA and FSSAI approved, BIS certified & ISO 17025 accredited analytical testing laboratory with internationa lexposure offering services to U.K., Egypt, Indonesia, Iran, U.A.E, Nigeria etc. rendering services to various industries from Pharmaceuticals, Cosmetics, Ayush, Chemicals, Food as per specific countries requirements.
Founded in 2009, Precise Analytics Lab has been consistently serving a diverse customer base that spans from individual clients to corporate entities.
Major Facilities & Test Parameters.
• Major Instrument :
1) HPLC with UV, RI and Fluorescent detector –
- All Active and Excipients, finish formulations such as Tablets, Capsules. Liquid Orals, Injectable and others.
2) GC / GC MS MS –
- Pesticide Residue, Known – Unknown Impurities, Fatty Acid Composition, Oil Testing, Active Mater (Assay), Residual Solvents.
3) LC MS MS –
- Antibiotics & Pesticide Residue, Known – Unknown Impurities, Active Mater (Assay), Nitrosoamines testing.
4) ICP-MS –
- Elemental Analysis as per ICH-Q3D guideline & Other Elements.
5) Pinnacle 500 (AAS) with MHS Technique –
- Heavy Metals and Elemental Analysis.
6) Ion Chromatography (IC) –
- Identification & content of Chloride, Sulfate, Sulfamate, Nitrate & Nitrites.
• MicrobiologicalAnalysis :
- Bacterial Endotoxins Test, microbiological assay (Vitamins & Antibiotics), Microbial Tests of water, Preservative Efficacy test, cosmetics, Food and pharmaceuticals for Microbial Limit tests, Environmental Monitoring.
• Other Services Offered :
- Method development, Validation, Stability testing, Photo Stability for API formulations, API testing & routine analysis.
Complete testing of Water as per guideline (BIS) of IS 10500: 2012, Packaged Drinking Water as per IS 14543, Packaged Natural Mineral Water IS 13428.
Visit our website: www.preciseanalytics.co.in
Analytica Control Services
We would like to introduce our organization “Analytica Control Services Pvt. Ltd” that specializes in the business of providing Pre-shipment inspection, Sampling and testing facility to various locations in all over India.
We are approved pre-shipment inspection agency and providing third party inspection service for Egypt and Israel. Right now we are providing our services to various pharmaceuticals i.e. Drug Formulations, Bulk Drugs, API Cosmetics, Pesticides, Food products, Marine products, Dairy products, Fruits and Spices which are being exported from India.
We are having a technical agreement with FDA approved analytical testing laboratories which are FDA, FSSAI, NABL, ISO and APEDA Accredited and have one of the best trained and competent staff in the Pharma industry to render this service.
We have one of the best trained and competent staff for inspection and sampling at manufacturing unit & at various Indian Sea and Air ports.
Visit our website: www.acslab.co.in
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Conference Next
SUPPORTED BY
Conference Alerts
SUPPORTED BY
International Conference Alerts
SUPPORTED BY
International Conference Alerts
SUPPORTED BY
Visit our website: https://internationalconferencealerts.com/
Testimonials
Fresenius Kabi Business Unit (BU) Head -Parenteral Nutrition
Organon Associate Director, Strategic Engagement & Vendor Management
Syneos Health Global Safety & PV Associate
Lupin Senior Executive
Mega Lifesciences Assistant Manager – Pharmacovigilance
George Clinical MSA
IQVIA Associate Manager
Wockhardt Head – Medical Affairs
SYNORBS BIOSOLUTIONS Director
Qtech Solutions CIO
Cipla Medical Services
Venue Details
Venue:
Hotel Kohinoor Continental
Address: Andheri Kurla Road, Andheri ( E ),
Mumbai – 400059
Maharashtra, India
Phone: 022 6769 3500
Get Involved
Speaking Opportunities
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
Sponsor / Exhibit / Delegate Bookings
E-mail us at
bookings@virtueinsight.com
+91 44 42108101
