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7th pharmacovigilance 2014
The document provides information about the 7th Pharmacovigilance conference taking place on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs through analyzing developments in pharmacovigilance, drug safety, and risk management. Key speakers from various pharmaceutical companies will discuss topics like signal detection, risk management plans, data collection and management, and regulatory expectations and updates. The conference is aimed at professionals in pharmacovigilance, drug safety, clinical research, and regulatory affairs. It will provide a platform for stakeholders to discuss best practices and challenges in the field.
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7th pharmacovigilance 2014
- 1. Conference Hashtag -#VI_Pharma 7th Pharmacovigilance 2014 21st November 2014, Kohinoor Continental Hotel, Mumbai, India “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance drug safety and risk management” KEY SPEAKERS:- Mazhar Maruf, Head of Pharmacovigilance, Glenmark Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi Abhay Chimankar, Head - Global Drug Safety, Cipla Rahul Chauhan, Associate Director – Regulatory Affairs & Pharmacovigilance, Eli Lilly Bhaswat Chakraborty, Senior Vice President, Cadila Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb Manish Verma, Director Medical Affairs, Sanofi Indu Nambiar, Clinical Safety Officer, Boehringer Ingelheim Amit Arora, Head Medical Affairs, Merck Serono Manish Shah, General Manager, Global Clinical Operations, Wockhardt V K Sharma, Associate Vice President, Unichem Laboratories Girish Parhate, Senior Manager – Regulatory Affairs, Bayer Kamlesh Patel, GM, Medical Affairs & Pharmacovigilance, Abbott Milind Antani, Head - Pharma LifeSciences, Nishith Desai Associates Vandana Jolad Shivangi, Director, VIaTAL Pharma Consulting Plus Many More...
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- 3. 7th Pharmacovigilance 2014 21st November 2014, Kohinoor Continental Hotel, Mumbai, India CONFERENCE INTRODUCTION:- After the successful journey of a series of 6 Pharmacovigilance yearly conferences, Virtue Insight is proud to announce its 7th Pharmacovigilance 2014 in India. India is now being recognized as the ‘Global pharmacy of generic drugs’ & has distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub of global clinical trials & a destination for drug discovery & development. India’s bio-pharma market forecast to reach $7 billion by FY2015. Pharmaceutical sales in India are expected to rise by 14.4 per cent to USD 27 billion in 2016 from last year, but the life sciences and health care industry is up against challenges such as quality management and meeting global standards. Pharmaceutical companies have been inspected by regulatory authorities for almost 15 years. This has meant that there is now a level of expectation from the regulators and industry that there has been enough time and knowledge to understand what is required as a responsible licence holder. companies need to ensure that all pharmaceutical products are managed properly in terms of the collection, assessment and reporting of adverse reactions such that any serious safety issues can be identified early and acted upon quickly to protect patients from harm. The aim of this conference is that through both a practical review of the purpose of internal audits to assess a company’s current systems and understand potential pitfalls, there is also a review of the current Regulatory attitudes and mechanisms for Inspections, the level of findings and penalties which are facing pharmaceutical companies – both big and small; innovator and generic. As the regulatory landscape continues to evolve it is crucial that you are keeping abreast of the changes impacting the drug safety industry to ensure that your pharmacovigilance strategies are robust and geared to compliance. In addition to this effective risk management and minimisation efforts and comprehensive benefit: risk analysis of drugs must lay the foundations for a strong drug safety strategy. 7th Pharmacovigilance 2014 will discuss the pressing concerns confronted with regard to drug safety, addressing the risks, time line, budget constraints, effectively tackling key challenges, overcoming trial agreement and site contract negotiation hurdles. Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development. The conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. It’s the latest in Virtue Insight’s series of successful pharmacovigilance events. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this event will provide an important platform for pharmacovigilance stakeholders from India to discuss and share best practices in expediting pharmacovigilance development in India It gives me great pleasure in welcoming all of you to the virtue insight’s 7th Pharmacovigilance 2014. I wish and pray that all our efforts will be beneficial to our industries and to our country at large. KEY THEMES DISCUSSED AT THIS CONFERENCE:- • Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions • Identifying the latest regulatory framework for pharmacovigilance • Crisis management within drug safety • Impact of technology – learn and explore • Explaining how to use the data sources and observational research for effective safety analysis • Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market • Stay ahead of computing and electronic communications in pharmacovigilance • Risk management plans • Risk/benefit determinations • Implications for safety reporting in global clinical trials • Compliance and drug safety • Training for drug safety - reporting duties, audits and expectations – risk based inspections • safety reporting in licensing agreement • Good supply chain management practices for medicine distribution • Accelerating new medicine introduction in developing world & overcoming challenges • Analyzing the information on current industry projects and trends • How will PV activities change with clinical trial transformation initiative? • Recent successful strategies and business models to bring out new medicines • Exploiting the pharmacy automations and technologies for enhancement of medication safety • Determining the steps and strategies for enhancing quality in healthcare WHO SHOULD ATTEND? Vice Presidents, Directors, CRO’s, Heads and Managers of: Pharmacovigilance Strategy, Drug Safety/Risk Management, Information and Clinical Data Management, Clinical Research, Research & Development, Product Safety/Assurance Assessment, Patient Safety & Outcomes Research & Data Analysis, Epidemiology project management, Regulatory Affairs and Compliance, Sales & Marketing, Biotech manufacturers TARGET AUDIANCE-INDUSTRY:- Pharmaceutical organisations, Generic pharmaceutical companies, Contract research organisations, Patient recruitment companies, Government- Department of health, Non-profit organisations/ Association, Consultans 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 drinks 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
- 4. 7th Pharmacovigilance 2014 21st November 2014, Kohinoor Continental Hotel, Mumbai, India 08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 09:30 – Morning Chair’s opening remarks V K Sharma, Associate Vice President, Unichem Laboratories (https://www.linkedin.com/pub/v-k-sharma/23/ba/197) 09:40 – Morning Keynote Address 1: Sharing the experience of Pharmacovigilance inspection in order to enhance internal readiness and to ensure good PV quality management • Revising GVP module I to stress on the importance of quality focus within the PV system and report filing • Improving internal readiness by enhancing the equipment and training of the individuals involved • Presenting inspection findings and disclose what authorities expect to see to ensure favourable reviews upon inspection • Revising methods to maintain up to date master files to comply with GVP guidelines • Providing advice and feedback on the creation of KPIs to determine the ideal strategy for business 10:10 – Evaluating the process excellence methods in ICSR operations to improve the quality and process efficiency • Introducing new opportunities of streamlining and developing processes to optimise data efficiency and quality at the same time • Discussing about the tools and solutions for efficient integration of regional site within the global system • Finding different ways of how technology can improve the process flow to maximise efficiency of data 10:40 – Morning Coffee/Tea & Networking 11:00 – Panel Discussion: Keeping updated with the opportunities and new technology offers to Pharmacovigilance research and surveillance • Reviewing current guidelines to check how the required information has to be treated, stored and reported in order to comply with guidelines • Investigating electronic tools to automatically screen the internet content and to extract relevant information from increasing signal volumes in order to reduce workload • Measuring the quality of information against the workload involved in order to ensure the success of social media strategy • Increasing opportunities to enhance patient interaction – from patient diaries to social media blogs – to get information on customer sentiment • Discussing the future role of social media in the pharmacovigilance research and safety processes to evaluate the benefits and challenges Moderator: V K Sharma, Associate Vice President, Unichem Laboratories (https://www.linkedin.com/pub/v-k-sharma/23/ba/197) Panellists: Manish Verma, Director Medical Affairs, Bhaswat Chakraborty, Senior Vice President, Sanofi Cadila (https://www.linkedin.com/pub/bhaswat-chakraborty/18/34/27) Manish Shah, General Manager, Global Clinical Operations, (https://www.linkedin.com/pub/manish-shah/18/678/1a2) Babita Kirodian, Head of Country Pharmacovigilance, 11:40 – Signals from detection to validation • What are the challenges faced in signal validation? • Role and differences in classical and statistical signal detection in the ongoing safety surveillance of medical products • Outline on how to apply signal detection within their function based on possibilities and limitations of methodology and data • Utilizing information gained through improved collaboration to improve investigation signals and find potential issues with drugs • Rising the internal communications to guarantee that signals are discovered as soon as possible and investigated to the best of the companies ability • Calculating the differences between signal detection in clinical trials and post-authorization to develop action plans for both 12:10 – Role of text mining in pharmacovigilance • Need to evaluate both structured and unstructured data in pharmacovigilance • Text mining for signal detection: is it a reality? • Applying text mining for the improvement of quality of pharmacovigilance databases • Understanding the role of signal detection to maximise your risk management and to minimise efforts Mazhar Maruf, Head of Pharmacovigilance, Glenmark (https://www.linkedin.com/pub/dr-mazhar-maruf/b/303/2b5) 12:40 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting... MARKET OVERVIEW & ANALYSIS CHALLENGES & OPPORTUNITIES SAFETY – SIGNAL DETECTION Wockhardt Bristol Myers Squibb (https://www.linkedin.com/pub/babita-kirodian/10/736/8bb)
- 5. 7th Pharmacovigilance 2014 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Milind Antani, Head - Pharma LifeSciences, (https://www.linkedin.com/pub/dr-milind-antani/3/792/22b) (https://www.linkedin.com/in/abhayphansalkar09) (https://www.linkedin.com/pub/dr-kamlesh-patel/2/1b1/324) 17:00 – Chairperson’s closing remarks and end of conference V K Sharma, Associate Vice President, Unichem Laboratories (https://www.linkedin.com/pub/v-k-sharma/23/ba/197) 17:10 - 18:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting. RISK MANAGEMENT & PLANNING 13:50 - Panel Discussion - Examining and sharing the best practice to overcome the challenges of preparing robust pharmacovigilance risk management and risk minimisation plans • Assessing the current complexities and controversies in pharmacovigilance and management of risk throughout all phases of development and marketed use • Exploring optimal strategies for risk assessment; case examples of risk assessments, minimisation methods and the challenges in performing high-quality risk management in a global environment • Understanding the complexities and requirements when identifying risk for generics and biosimilars; what additional considerations are made for these products if any? Indu Nambiar, Clinical Safety Officer, (https://www.linkedin.com/in/drkarthikbabu) (https://www.linkedin.com/pub/girish-parhate/1b/704/100) 14:30 – Identifying and implementing the tools to measure and refine risk management plans and to minimise risk • Improving and adjusting risk management process by measuring them correctly • Using different tools and showcasing their direct impacts on a company’s drug risk minimisation strategies • Sharing practical examples of risk minimisation and highlighting the positive and negative outcomes • Presenting feedback from agencies in order to verify the effectiveness of the applied tools 15:00 – Improving quality systems that ensure valuable data for timely reactions to potential flaws and increased patient safety • Producing quality systems to be implemented to bring together the data received and evaluate cases effectively • Integrating the newest legislation in order to improve quality management systems and satisfy regulators • Troubleshooting problems that arise from poor quality data or data which reveals issues with the drugs to improve patient safety • Integration of the quality systems across all affiliates to be sure that high standards are met across the company 15:30 Afternoon Coffee/Tea & Networking – 15:50 – EU regulations and its impact Abhay Chimankar, Head - Global Drug Safety, Cipla (https://www.linkedin.com/pub/abhay-chimankar/a/794/5a8) 16:20 – Panel Discussion: Overall regulatory expectations - Feedback on current risk • Providing guidance on legislation – GVP Module V and XVI – to clarify authority expectations and to avoid speculation and differing interpretation of the current guidelines • Delivering inspection results and experiences in order to address the uncertainty surrounding the content and effectiveness of existing risk minimisation plans • Recognising the importance of consistency and common industry standards to define important and unimportant risks • Increasing focus on patient communication to guarantee maximum patient safety • Introducing new risk minimisation measures and assessing their effectiveness • Addressing the challenges of combining global and local RMPs to identify possible improvements • Collaboration with internal stockholders : Medical Affairs , QC, PV and Regulatory • Ambiguity and grey area regarding Branded Genrics vs Innovator products for PV aspects- Indian perspective and current status Moderator: Panellists: Rahul Chauhan, Associate Director – Regulatory Affairs & Pharmacovigilance, Abhay Chimankar, Head- Global Drug Safety, Kamlesh Patel, GM, Medical Affairs & Pharmacovigilance, Amit Arora, Head Medical Affairs, Nishith Desai Associates Eli Lilly Cipla Abbott Merck Serono (https://www.linkedin.com/in/arora007) DATA COLLECTION & MANAGEMENT REGULATION OVERVIEW & UPDATE Moderator: Panellists: Karthik Babu, Affiliate Pharmacovigilance Head, Girish Parhate, Senior Manager – Regulatory Affairs, Vandana Jolad Shivangi, Director, Boehringer Ingelheim Sanofi Bayer VIaTAL Pharma Consulting
- 6. FLOOR PLAN:- Bookyour stalls now before they run out !!! FLOOR PLAN - Book your stalls now before they run out !!! 1 7th Pharmacovigilance 2014 3 2 5 3 4 CONFERENCE HALL 1 CONFERENCE HALL 2 CONFERENCE HALL 3 1 Coffee / Tea / Networking Area POOL SIDE AREA NETWORKING LUNCHEON 4 5 6 2 REGISTRATION DESK 6 7 7
- 7. Partial list ofattendees from our previous Pharmacovigiliance:- Abbott Accenture Services Accutest Research Laboratories Acunova Adcock Ingram Healthcare Agilent Technologies Ajanta Pharma Ajaxdotcom Alembic Pharmaceuticals Amgen Technology Apollo Hospitals Aris Global, Arklus CTSS Astellas Pharma Astrazeneca Bagdad medical college Baxter Bayer Health Care Bayer Pharmaceuticals Bharat Serums & Vaccines Biocon BioScreening BioSpectrum India Bluefish Pharmaceuticals BMS Bodhi Global Boehringer Ingelheim Bookmytraining.com Bristol Myers Squibb Business Vibes Cadila CADILA CRO Cadila Pharmaceuticals Center for Cellular & Molecular Biology Chiltern International Cipla CISCO SYSTEMS Clinical Research & Healthcare Clinigene International Cliniminds Clininvent Research Cognizant Technology Solutions CSIR Emeritus Scientist DBMS Consulting DNA India Dr Lal Path Labs Dr Reddys Ecron Acunova Ege University Elder Pharmaceuticals Eli Lilly Eli Lilly & Company Ennovent Express Pharma EXTEDO Famy Care FDC Forte Researce Fresenius Kabi Oncology Fulford Generic Licensing Glenmark Generics Global PharmaTek Going to Meet Good Compliance Services HCL Technologies - BPO Services i3 Research ICR IIHMR Indian Immunologicals Innovaro Inventia Healthcare Ipca LaboratoriesI ITS-DCHRC JASIC Asia Bio Network JB Chemicals & Pharmaceuticals Johnson & Johnson K.J Somaiya Medical College Karmic Labs Karmic Lifesciences KEM Hospital Kinapse KPMG L.T. Medical College Lambda Therapeutic Research Launtech Teaching Hospital LG Life Sciences India Pvt. Ltd Lotus Labs Lupin Limited Macro Care Maharashtra University of Health Sciences Medical Newstoday Mega Lifesciences MGM School of Biomedical Sciences Micro Therapeutic Research labs MMS MSD India Mumbai University Mylan Laboratories Niko Infra Licensing Nishith Desai Associates Norwich Clinical Services Novartis Oracle Life Sciences Oviya MedSafe Panacea Biotec Pfizer PharCast Pharma & Healthcare Insights Pharma Asia Pharma Focus Asia Pharma Mirror Pharmacovigilance.co.in pharmaphorum PharmaVOICE Piramal Life Sciences Plethico Pharmaceuticals PPCE Pvt. Ltd Provenance research PVCON Pharmacovigilance Consulting Services- India Quintiles Raaj GPRAC Ranbaxy Research Laboratory Rasayani Biologics RegPak BioPharma Consulting Reliance Life Sciences Research and Marketing Roche Products Saffron Media Sanofi Aventis Sciformix Technologies SIRO Clinipharma SLARC SRL Sun Pharmaceutical Industries Swami Samarth Pharmatech Synowledge TAKE Solutions Tata Consultancy Services TCS Tech Observer Techsol Techsol Corporation Torrent Pharmaceutical Ltd Torrent Research Center Until ROI Veeda Clinical Research VIVAN Life Sciences Voisin Consulting Life Sciences Watson Pharma Wipro Wockhardt Wockhardtin World Pharma Today Xylem Clinical research YourStory.in
- 8. Registration Form 21stNovember 2014, Kohinoor Continental Hotel, Mumbai, India Queries: Should you have any questions on bookings, Please feel free to contact us. Email: info@virtueinsight.com Web: http://www.virtueinsight.com India Office: Tel: +91 044 64536444 General information Venue: Kohinoor Continental Hotel Andheri Kurla Road Andheri ( E ) Mumbai 400059 - India Tel: 91 22 66919000 / 91 22 28209999 Payment terms: Virtue Insight requires the full amount to be paid before the conference. Virtue Insight may refuse entry to delegates who have not paid their invoice in full. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, or email. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences and executive briefings. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organization and are not transferable between countries. Indemnity: Virtue Insight reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a situation arises, we will refund your registration fee and we will try to reschedule the event. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel or hotel accommodation. How we will contact you: Virtue Insight's preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. News Updates: Please tick if you do not wish to receive email updates in the future RESERVATION PRICING: Early Bird Discount Rate Till 07th October 2014 1 Day conference per delegate - Fee: INR 06,000 + Tax Standard Rate (From 08th October 2014) 1 or 2 delegates - per delegate - Fee: INR 07,000 + Tax Group Discounts 3 or 4 delegates - per delegate - Fee: INR 06,500 + Tax Group Discounts For 5 and above delegates - per delegate - Fee: INR 06,000 + Tax Spot Registration:- 1 Day conference per delegate - Fee: INR 08,000 + Tax www.virtueinsight.com Registration Form Details: Forename ............................Surname ................................ Job Title ..............................Company ................................ Official Contact Number ....................................................... Address ............................................................................. ............................................................................. Country ...............................Postcode.................................. Phone ..................................Fax ........................................ Email ................................................................................. I confirm that I have read & agree to the terms and conditions of booking..... (Please Tick) Signature ........................................................................... Methods of Payments: By Cheque - Complete and return the above registration form via post or email, together with your cheque payable to Virtue Insight. By Bank Transfer: Account Name - Virtue Insight Account Number - 830092431 Sort code - IDIB000V080 Bank Address - Indian Bank. 118 - 119, Indira Nagar, Valasaravakkam, Chennai 600 087,Tiruvallur district,Tamil Nadu, India