5th pharmacovigilance congregation 2013

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Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.

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5th pharmacovigilance congregation 2013

  1. 1. Conference Hashtag - #VI_Pharma 5th Pharmacovigilance Congregation 2013 20th November 2013, Kohinoor Continental Hotel, Mumbai, India “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance drug safety and risk management” Key Speakers Include:Deepa Arora, Global Head, Drug Safety & Risk Management, Lupin Arun Bhatt, President, Clininvent Research Prashant Bodhe, Director, CliniSearch Chetna Desai, Professor of Pharmacology, BJ Medical College (Ahmedabad) Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant (QPPV), RegPak BioPharma Consulting (Netherlands, UK) Babita Kirodian, Head - Pharmacovigilance, Bristol-Myers Squibb Rajani Rokade, Head - Pharmacovigilance, Sanofi Aventis Veena Rajan, Head - Patient Safety, AstraZeneca Sofi Joseph, Head - Regulatory Operations, Pfizer Manish Mistry, Medical Director, Novartis Abhay Chimankar, Global Safety Officer, Cipla Manish Shaw, Head Pharmacovigilance, Wockhardt Girish Parhate, Senior Manager – Regulatory Affairs, Bayer Indu Nambiar, Clinical Safety Officer, Boehringer Ingelheim Deepti Sanghavi, Senior Medical Writer - Medical Writing, SIRO Clinpharm Milind Antani, Head – Pharma LifeSciences group, Nishith Desai Associates Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson Plus Many More...
  2. 2. 5th Pharmacovigilance Congregation 2013 20th November 2013, Kohinoor Continental Hotel, Mumbai, India SILVER PARTNER ASSOCIATE PARTNER BRONZE PARTNER EXHIBITOR SUPPORTED BY ORGANIZED BY
  3. 3. 5th Pharmacovigilance Congregation 2013 20th November 2013, Kohinoor Continental Hotel, Mumbai, India CONFERENCE INTRODUCTION:After the successful journey of our previous 4 years of annual Pharmacovigilance conferences, Virtue Insight is proud to announce its 5th Pharmacovigilance Congregation 2013 in India. The emerging markets are rapidly evolving to compete with the standards set by the developed world. Many life sciences companies in India are now focusing strongly on drug safety management and pharmacovigilance. Demand from emerging markets is opening up various opportunities across multiple sectors. Life sciences companies have several compelling reasons to build a presence in emerging markets. By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey. The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any new information available in relation to their safety profile. In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programme for the nation. Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines. More clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product. A good pharmacovigilance will easily identify the risk factors in the shortest time so that the harmful effects can be avoided or minimized. 5th Pharmacovigilance Congregation 2013 will discuss the pressing concerns confronted with regard to drug safety, addressing the risks, time line, budget constrains, 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. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this conference 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 5th Pharmacovigilance Congregation 2013. 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:• • • • • • • • • • • • • • • • • • Exploiting the latest technologies, methodologies & automations on work practices of Pharmacovigilance Keeping abreast of the changes impacting the drug safety industry to ensure the pharmacovigilance strategies are robust and geared to compliance Recent successful strategies and business models to bring out new medicines How will PV activities change with Clinical Trial Transformation Initiative? Identifying essential antidote requirements and learn to implement best practices in drug safety and surveillance Exploiting the pharmacy automations and technologies for enhancement of medication safety Stay ahead of computing and electronic communications in pharmacovigilance Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market Establishing the importance of pharmacovigilance for the safety of the patient Determining the steps and strategies for enhancing quality in healthcare Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions Analyzing the information on current industry projects and trends Identifying the latest regulatory framework for pharmacovigilance Global marketing strategies in order to engage with regulatory centres of excellence on pharmacovigilance Accelerating new medicine introduction in developing world & overcoming challenges Explaining how to use the data sources and observational research for effective safety analysis Good supply chain management practices for medicine distribution Be part of a major networking opportunity 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 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. 4. 5th Pharmacovigilance Congregation 2013 20th November 2013, Kohinoor Continental Hotel, Mumbai, India 08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 11:30 – Morning coffee & Discussion 11:50 – Signal Detection in Pharmacovigilance 09:30 – Morning Chairperson opening remarks Prashant Bodhe, Director, CliniSearch (http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5) 09:40 – Morning Keynote Address 1: Impact of Recent Regulations on Pharmacovigilance in India • • • • • Recent compensation rules Reporting process SAE - related to trial or drug Causality assessment Safety data base - local / global drug development Arun Bhatt, President, Clininvent Research • • • • • 12:20 - Generating and assessing critical safety data during development • • • • (http://www.linkedin.com/pub/arun-bhatt/5/431/958) 10:20 – Morning Keynote Address 2: Bridging the gap of clinical trial pharmacovigilance to post-marketing phase • • • Understanding the various deliverables starting from the clinical phase How to gather the safety information data during clinical trials and reflect the same into post marketing activities? Assessing the risks and new information gathered after marking and its effect on the ongoing trials as well as the post marketing phase Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant (QPPV), RegPak BioPharma Consulting (Netherlands, UK) Methods and effective detection of signals Role of IT in enhancing signal detection effectiveness Regulatory requirements & approach to signal detection Importance of astute clinical perspective What are the consequences of over-reliance on technology Work to international standards by meeting regulatory requirements for product safety Perform signaling and risk management functions Collect, assess, report, and analyze adverse events Create signaling analyses based on FDA Good Pharmacovigilance Practices 12:50 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting... Afternoon Chairperson opening remarks Prashant Bodhe, Director, CliniSearch (http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5) 13:50 – Afternoon Keynote - Panel Discussion - In pharmacovigilance where does fault lie? (http://www.linkedin.com/pub/parminderkaur/3/6b2/5b4) 10:50 – Panel Discussion: What are the latest challenges in pharmacovigilance and the opportunities? • • • • • • Challenges to PV compliance currently Extensive use of traditional medicines and poor spontaneous reporting Rapid introduction of several new molecules and inadequate post marketing surveillance Identifying the key opportunities for biopharmaceutical outsourcing in the area of PV Litigation, risk and latest developments and trends within PV technology Case studies: what can we learn from successful experiences from RoW? • • • • • • • Updates on ADR reporting requirements Adequate sharing of information between stake holders No rapport with practising physicians & peripheral centres Increasing availability of drugs, due to which too many drugs and irrational combinations and aggressive marketing Irrational practice of treatment without provisional diagnosis, Wrong choice & incorrect dose, lack of documentation, Resultant medical errors leading to ADEs and not necessarily ADRs Pharmacovigilance Audits from a Sponsor’s Perspective: Risk Management Plans (RMPS) & Risk Evaluation Mitigation Strategy (REMS) Moderator – Prashant Bodhe, Director, CliniSearch (http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5) Moderator – Panelists – Prashant Bodhe, Director, CliniSearch Babita Kirodian, Head Pharmacovigilance, Bristol-Myers Squibb (http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5) (http://www.linkedin.com/pub/babita-kirodian/10/736/8bb) Panelists – Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant (QPPV), RegPak BioPharma Consulting (Netherlands, UK) Veena Rajan, Head, Patient Safety, AstraZeneca (http://www.linkedin.com/pub/parminderkaur/3/6b2/5b4) (http://www.linkedin.com/pub/veena-rajan/9/533/375) Chetna Desai, Professor of Pharmacology, BJ Medical College (Ahmedabad) (http://www.linkedin.com/pub/chetna-desai/9/40/92b) Rajani Rokade, Head - Pharmacovigilance, Sanofi Aventis (http://www.linkedin.com/pub/dr-rajani-rokade/22/89a/521) Manish Shaw, Head Pharmacovigilance, Wockhardt Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson (http://www.linkedin.com/pub/dr-anish-desai-m-dfcp/8/966/800)
  5. 5. 5th Pharmacovigilance Congregation 2013 20th November 2013, Kohinoor Continental Hotel, Mumbai, India 14:30 – Benchmarking Drug Safety and Pharmacovigilance • • • • • • How to choose among the available drug safety vendors Discover how to improve supplier-client relationship How to optimize and strengthen your drug safety team? Importance of improving your communication with the FDA Identify the most important challenges towards improved safety and monitoring of drugs. Aligning the team and assigning responsibilities for investigational and post-market products Abhay Chimankar, Global Safety Officer, Cipla (http://www.linkedin.com/pub/abhay-chimankar/a/794/5a8) 15:00 – Afternoon Coffee & Discussion 15:20 – Pharmacovigilance Benefit/Risk assessments and striking the right balance • • • • Risk management throughout a product’s lifecycle: integrated safety business Implementation and monitoring of a risk management plan Maintaining constant pharmacovigilance and making the best pre and post marketing safety judgements Making accurate determinations of whether a product is in fact safe and what can alter the determinations 16:20 – Panel Discussion: Update on Indian PV regulations & Overcoming regulatory challenges in Asian PV market –Today & Tomorrow • • • • • • Update on PVPI, India regulation - way forward Developing regulatory strategies for new products which comply with global safety requirements ICMR guidelines’ impact on pharmaceutical industry –how to adjust to the new guidelines? Clarifying PV and ADR reporting guidelines and fields Strategic challenges in the evolution of Indian PV regulations in next decade Keep abreast with the changing International regulations of PV Moderator – Milind Antani, Head – Pharma LifeSciences Group, Nishith Desai Associates (http://www.linkedin.com/pub/milindantani/2/69a/5b5) Panelists – Deepa Arora, Global Head, Drug Safety & Risk Management, Lupin (http://www.linkedin.com/pub/deepa-arora/31/67a/794) Sofi Joseph, Head – Regulatory Operations, Pfizer (http://www.linkedin.com/pub/sofi-joseph/12/307/632) 15:50 – Panel Discussion - PV Audit & inspections preparation, implementation and lessons to be learnt • • • • • What are relevant interactions during the PV inspections Audits to develop, establish, promote and align with international standards Identifying best criteria for PV inspections to maintain constant vigilance Standardizing PV auditing procedures Integrating PV into clinical practice, through training and education Indu Nambiar, Clinical Safety Manager, Boehringer Ingelheim (http://www.linkedin.com/pub/indu-nambiar/7/1a8/8a) Girish Parhate, Senior Manager – Regulatory Affairs, Bayer (http://www.linkedin.com/pub/girish-parhate/1b/704/100) 17:00 – Afternoon Chairperson's closing remarks Prashant Bodhe, Director, CliniSearch (http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5) Moderator – Deepti Sanghavi, Senior Medical Writer, SIRO Clinpharm (http://www.linkedin.com/pub/dr-deepti-sanghavi/5/591/b76) Panelists – Abhay Chimankar, Global Safety Officer, Cipla (http://www.linkedin.com/pub/abhay-chimankar/a/794/5a8) Manish Mistry, Medical Director, Novartis (http://www.linkedin.com/pub/manish-mistry/9/479/34a) 17:10 - 18:00 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting.
  6. 6. 5th Pharmacovigilance Congregation 2013 FLOOR PLAN - Book your stalls now before they run out !!! 2 1 CONFERENCE HALL 2 3 CONFERENCE HALL 3 POOL SIDE AREA NETWORKING LUNCHEON CONFERENCE HALL 1 5 4 Coffee / Tea / Networking Area REGISTRATION DESK 7 6 1 4 2 5 3 6 7
  7. 7. Partial list of attendees 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 Quintiles Glenmark Generics Raaj GPRAC Global PharmaTek Ranbaxy Research Laboratory Going to Meet Rasayani Biologics Good Compliance Services RegPak BioPharma Consulting HCL Technologies - BPO Services Reliance Life Sciences i3 Research Research and Marketing ICR Roche Products IIHMR Saffron Media Indian Immunologicals Sanofi Aventis Innovaro Sciformix Technologies Inventia Healthcare SIRO Clinipharma Ipca LaboratoriesI SLARC ITS-DCHRC SRL JASIC Asia Bio Network Sun Pharmaceutical Industries JB Chemicals & Pharmaceuticals Swami Samarth Pharmatech Johnson & Johnson Synowledge K.J Somaiya Medical College TAKE Solutions Karmic Labs Tata Consultancy Services Karmic Lifesciences TCS KEM Hospital Tech Observer Kinapse Techsol KPMG Techsol Corporation L.T. Medical College Torrent Pharmaceutical Ltd Lambda Therapeutic Research Torrent Research Center Launtech Teaching Hospital Until ROI LG Life Sciences India Pvt. Ltd Veeda Clinical Research Lotus Labs VIVAN Life Sciences Lupin Limited Voisin Consulting Life Sciences Macro Care Watson Pharma Maharashtra University of Health Sciences Wipro Medical Newstoday Wockhardt Mega Lifesciences Wockhardtin MGM School of Biomedical Sciences World Pharma Today Micro Therapeutic Research labs Xylem Clinical research MMS YourStory.in 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
  8. 8. Registration Form 20th November 2013, Kohinoor Continental Hotel, Mumbai, India Early Bird Discount.. For Multiple Bookings Photocopy this form... Book & Pay before 07th October 2013 Early For Multiple Bookings Bird Discount Rate Early Bird Discount Rate (Register & Pay before 11th April 2012) 1 Day conference per delegate - (Please Tick) Fee: INR 4,000 + Tax Standard Rate After 11th April 2012 INR (Please Tick) 1 Day conference per delegate - Fee: INR 06,000 + Tax Group Bookings (Please Tick) For 2 or 3 delegates - per delegate - Fee: INR 05,000 + Tax For 4 and more delegates -per delegate - Fee: INR 04,000 + Tax Exhibition Visitor Pass Fee: Free 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 Bank Address - Indian Bank. 118 - 119, Indira Nagar, Valasaravakkam, Chennai 600 087,Tiruvallur district,Tamil Nadu, India Photocopy this form... Register & Pay before 07th October 2013 (Please Tick) 1 Day conference per delegate Special Price INR (Please Tick)Fee: INR 04,000 + Tax Standard Rate 07th October 2013 INR 07,000 + Tax Tick) (Please 1 Day conference Fee: For 1 or 2 delegates - per delegate - Fee: INR 05,000 + Tax Group Bookings Form Details: Registration (Please Tick) For 3 and above delegates - per delegate - Fee: INR 04,000 + Tax Forename ............................Surname ................................ Spot Registration:Job Title ..............................Company ................................ 1 Day conference per delegate - Fee: INR 06,000 + Tax Official Contact Number ....................................................... Registration Form Details: Address ............................................................................. Forename ............................Surname ................................ ............................................................................. Job Title ..............................Company ................................ OfficialCountry ...............................Postcode.................................. Contact Number ....................................................... Phone ..................................Fax ........................................ Address ............................................................................. Email ................................................................................. ............................................................................. I ...............................Postcode.................................. Country confirm that I have read & agree to the terms and conditions of booking..... (Please Tick) Phone ..................................Fax ........................................ Signature ........................................................................... Email ................................................................................. Methods of Payments: By Cheque - read & agree return I confirm that I haveComplete and to the the above registration form via post or email, of booking..... (Please Tick) terms and conditions together with your cheque payable to Virtue Insight. By ........................................................................... Signature Bank Transfer - Queries: Queries: Email to delegate@virtueinsight.com Should you have any questions on bookings, Should you have any questions on bookings, Please feel free to contact us. Please feel free to contact us. Email: info@virtueinsight.com Email: info@virtueinsight.com Web: http://www.virtueinsight.com Web: http://www.virtueinsight.com India Office: Tel: +0091 44 2377 0517 India Office: Tel: +0091 44 6453 6444 General information Venue: General information Venue: Kohinoor Continental Hotel Payment terms: Mumbai Virtue India 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. Payment terms: Virtue Insight requires the full amount to be paid before the Substitutions/name changes or cancellations: conference. Virtue Insight may refuse entry to delegates who have There is a 50% liability on all bookings once made, whether by post, not paid their invoice in full. 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 Substitutions/name changes or cancellations: to cancel after this date, the full invoice must be paid. Conference There is will then be sent to you. Unfortunately, we are unable to transfer notes a 50% liability on all bookings once made, whether by post, fax, or email. There is a no refund policy for cancellations received you places between conferences and executive briefings. However, if on or after one month before theyou may the event. Should you decide cannot attend the conference, start of make a substitution/name tochange after this date, the full invoice must be paid. Conference cancel at any time, as long as we are informed in writing by email, notes or post. Name changes and substitutions must be fromto transfer fax will then be sent to you. Unfortunately, we are unable the same places between conferences and executive briefings.between countries. company or organization and are not transferable 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, Indemnity: fax or post. Name changes and substitutions must be from the same Virtue Insight reserves the right to make alterations to the company or organization and are not transferable between countries. conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to Indemnity:events beyond the control of Virtue Insight. If such a unforeseen Virtue Insight reserves the right to make alterations to thewe will try situation arises, we will refund your registration fee and conference/executive briefing content, timing, speakers or venue to reschedule the event. without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a Fee: situation arises, we will refund your registration fee and we will try The conference fee includes lunch, refreshments and conference papers to reschedule the event. provided on the day. This fee does not include travel or hotel accommodation. Fee: The conference fee includes lunch, refreshments and conference papers How we will contact you: provided on the day. This fee does not include travel or hotel Virtue Insight's preferred method of communication is by email and accommodation. phone. Please ensure that you complete the registration form in full so that we can contact you. 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. Account Name - Virtue Methods of Payments: Insight Account Number - 830092431 Bank - Complete and Bank. By Cheque Address - Indianreturn the above registration form via post or118 - 119, Indirawith your cheque payable to Virtue Insight. email, together Nagar, Valasaravakkam, Chennai 600 087,Tiruvallur district,Tamil Nadu, India By Bank Transfer: News Updates: Please tick if you do not wish to receive email updates in the future 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 www.virtueinsight.com www.virtueinsight.com

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