"Overseeing risks and Optimizing drug safety in todays pharma market"
- Reviewing the best revenue generating models in suitable for current and future PV market.
- Grabbing the opportunity: learning about the challenges & complexities in the role
- Best practices, service offerings & deployment
- Global marketing strategies in order to engage with regulatory centres of excellence on pharmacovigilance and to understand their perspectives on best practice & future trends
- Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
- Exploiting the role of electronic data standards and controlled vocabularies in pharmacovigilance
- Positioning yourself in light of new market entries
- Analyzing the worldwide trends in PV & lessons for India.
- Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
- Updating yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV
- Dwell ahead of regulatory developments & improving your risk management strategies in a cost effective way
Key Speakers
- Akhilesh Sharma, Vice President & Global Head Clinical Management & Global Pharmacovigilance, Dr. Reddy’s
- Zoher Sihorwala, Vice President Global Regulatory Affairs, Dr. Reddy’s
- Veena Rajan, Head - Patient Safety, AstraZeneca
- Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Management Clinical Research, Pfizer
- Simrat Sohal, Head - Pharmacovigilance, Eli Lilly
- Bhaswat S. Chakraborty, Senior VP, R&D, Cadila Pharmaceuticals
- Prashanth BSB, Medical & Safety expert (Regulatory Affairs), Cipla
- Deven Parmar MD, Vice President - Clinical Research & Pharmacovigilaance, Wockhardt
- Subbaraju Sagi, Senior Solutions Consultant, Oracle Life Sciences
- Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates
- Arani Chatterjee, Vice President, Clinical Research, Panacea Biotec
- Siddarth S. Chachad, Medical & Safety Expert (Regulatory Affairs), Cipla
- Dipti Kadam, Consultant - Clinical technology & System, DBMS Consulting
- Vishwas Sovani, MD, VP, Pharma Delivery, TCS
- Mahesh Malneedi, President, Macro Care
- Arun Bhatt, President, Clininvent Research
- Parminder Kaur, Managing Director, RegPak BioPharma Consulting
- Arunima Sen, Manager Medical Team, MMS Holdings Incorporation
- Krathish Bopanna, Senior Vice President, Acunova
- Sanjay Zodpey, Director, Public Health Foundation of India
- Gopal Pande, Scientist, Center for Cellular & Molecular Biology
Conference Summary:
INTRODUCTION
Below mentioned is a succinct gist on the ongoing Pharmacovigilance 2010 conference conducted in Mumbai on the 21st and 22nd of Jan, 2010 at the ITC Maratha (Sahar) Hotel. These are points and thoughts that have been discussed or pointed out in open forum, other than the slide material
The conference was well planned and set up by Virtue Insight and was attended by the who’s who of the industry as speakers, sponsors and delegates alike.
DAY 1
Mr. Manoj Sharma, Group head, Panacea Biotech
The Chair’s opening remarks was a refreshing start to the day. He shared a few pointers on the Pharmaceutical Industry as well as the Regulatory Authorities of which there was, overall, more emphasis on the EMEA or European Regulatory Authorities as well as the US-FDA.
Mr. Akhilesh Sharma, VP & Global head Clinical Mngmt & Global PV, Dr. Reddy’s
The first speaker/ presenter of the day on the latest developments in PV. The following were the key points touched upon:
- A gist of the CIOMS as well as ICH guidelines that drive the industry and its practices
- In 2001 the actual guideline was put into practice
- Updates on new molecules come from the RA and not the MAH due to nature of evaluation of safety signals
- Generic drug SPC (Summary of Product Characteristics) updates do follow strict RA guidelines but are rarely made a priority from the MAH’s side
- A complete oversight of the PV system is required
- From Jan-2010, the FDA will no longer accept paper submissions and would replace this practice with electronic submissions through an E2B gateway
- Discussion on DDPS (Detailed Description of PV system), REMs and Signal detection
- Notifications will be provided alongside renewals for products already in the market
- The need for finer definitions and clauses of various aspects of PV and safety reports
- Risk-Benefit Information: If and when a product is registered and launched in one market and there follows a recall (for any reason), restriction or variation, then the changes or signals should not be restricted to the market in question. It is required (rather anticipated) that such information should be shared through a Global Integration network irrespective of which country the product is marketed in.
- There should also be a stable backup to the databases for storing and submitting documents i.e. ANVISA, FDA, EU. ANVISA also facilitates the translation of the document/report from English to Portuguese for the purpose of submission in local language in Latin countries such as Brazil and Venezuela
- The job description, availability and use of QPPV (Qualified Person in PV) should be well defined, outlined and standardised across all regulatory bodies.
- Revisiting the practice and need for SOPs in the industry; of specific interest was having an SOP on designing an SOP and also an SOP for the recall of an SOP.
- PSUR: The need for harmonized sharing and submission practices of PSURs so as to avoid repetitive submissions to the RA
- Discussions on Vol. 9A: of interest was V3: use of drugs in pediatric population, new vaccines and drugs for flu and pandemics (recent health scares) and lack of efficacy in case of vaccines e.g. recall of a few million units of a vaccine in the USA
- Emphasis on simplifying, rationalizing and reducing duplication of ADR submissions
- PV master files to replace DDPV
- The importance of PASS (Post Authorization Safety Studies) by the US-FDA
- Anticipated changes in the EU parliament to take around 2 years following which or running in parallel for the same would be the FDA.
- A new electronic submission format HL7 as per the ICSR which is currently in draft mode and is yet to acquire an ISO certification
- Another point stressed on was the outsourcing practices of MAHs’ and the fact that despite outsourcing their business or practices, the MAH would still remain accountable for all end results
- During the Q&A session, Mr Sharma stated that there would be separate and mandatory REMs and RMPs for biosimilars and sadly the paper submission practices or lack of progress where the DCGI (India
Subbaraju Sagi, Sr. Solutions Consultant, Oracle Life Sciences
Mr. Sagi provided an IT perspective and requirement of the industry. He threw light on the Oracle ARGUS database and its various applications and features to ‘fit the bill’ where PV was concerned. The following are few points of interest:
- Discussion on past predictions (2009) and future predictions as well (2010)
- Highlights on Cloud computing and SAS programmes. The pharmaceutical companies will mitigate their IT structure to include these features
- The need for full spectrum monitoring of the molecule right from Clinical Trials and not just PMS (post marketing surveillance)
- An IT perspective on REMs, RMPs and signal detection
- There is a need for IT management and risk management which fall under 2 categories: Potential or suspected risk (no evidence) and Identified or evidence based risk (data to support the findings)
- ARGUS PERSPECTIVE the new software for risk management framework
- Safety data mart = compilation of all safety databases and information
- During Q&A session, Mr Sagi was provided clarification on the EMEA – RMP submissions which are mandatory and not ‘as requested’ which was stated so
- For the integration and flexibility of new SAS applications (algorithms) which are yet not installed/ available in ARGUS: ETL connects to SAS. Data can be imported – converted – exported for customized applications.
Sanish Davis, Clinical Research Manager, PGRD, Pfizer
The presentation was based on clinical safety reporting using DSUR (Drug Safety Update Report) and post-marketed (approved) drugs using PSUR (Periodic Safety Update Report).
- DSURs for investigational drugs are in stage IV as of Jun-2009. The same is expected to proceed further to Stage V in 2010.
- It comprises the template of IND Annual reports as well as ASRs for the EU
- Provided a succinct difference between IND-ARs vs. ASRs which also provided harmonization of CSR
- DSUR guidelines included RA constraints with respect to content as well as molecule specific requirements e.g. vaccines would call for immunology data
- Section of interest in the DSUR template-section 1.2.B. Plan for coming year which discusses upcoming studies (e.g. BA/BE, safety), trials, any planned studies with objective and possible schedule for the same. Also in some cases if development for a molecule was halted and restarted after a significant time period can be highlighted in this section. Safety data for such molecules can be used from the previous development data till it was stalled.
- Limitations of the DSUR: consistency issues with ICH i.e. stringent guidelines which cannot be bent and the possibility of ASRs being replaced with DSURs.
- Q&A: Clarification on submissions to specific authorities
PANEL DISCUSSION
Moderated by Milind Antani (Head Pharma Life Sciences Grp, Nishith Desai Associates)
Arunima Sen, Manager Medical Team, MMS Holdings Inc.
Veena Rajan, Head – Patient Safety, Astra Zeneca
Manoj Sharma – Group Head PV, Panacea Biotec
Points discussed:
- Upcoming markets – developing world such as India
- Limitations and drawbacks discussed such as lack of patient data, patient exposure, poor reporting system
- No safety reports and lack of defined guidelines from DCGI
- Lack of uniformity in requirement and submission of data e.g. what and when does DCGI require blinded vs. unblinded data
- Once the ADRs are reported or safety reports and clinical documents are submitted there us no feedback from the RA (India
- Ironically, the MAHs are satisfied and not concerned as there is no probe or stringent action taken or demanded of them or their practices
- Too many generics are readily available in the market = too many ADRs due to off-label use of the drug by a significant percentage of the population
- There are no updates RSIs or PILs especially safety updates in case of generic molecules
- Lack of consistency between HCP (Physicians) prescribing the drug and the event being reported to a different HCP. Lack of medical history data and more specifically what drugs the patient’s have been taking
- Poor reporting by HCPs as well as lack of motivation to do so
- Lack of qualified personnel/ professionals in the field.
- Points to battle the above challenges: training the company personnel so as to have them communicate the same as priorities to the consumer as well as HCPs
- Need for robust training on the RA requirements, documents to be submitted and guidelines for the same
- Need to tackle poor PV awareness even among educated masses and HCPs
- CROs must be audit ready and ISO certified
- PSURs for submission to the DCGI face challenges such as lack of data and information on safety or patient exposure.
- Indian HCPs are reluctant to report any ADRs or accept RMPs
- A few examples (ray of hope) was highlighted by ‘Dear Investigator’ letters issued by Sanofi Aventis during their DILI (drug-induced liver disease) trials
- Challenges: Even if sales reps were educated or trained, they would not proactive participate or practice the same in the field. They have their own prerogatives and targets to meet wherein PV or educating the masses is not a priority.
- HCPs are given top priority and blindly relied on by the consumers. Consumers are unaware of the existence of a reporting system or the correct reporting methods.
- Increased incidences of off-label use of drugs
- IPs are limited to safety
- DCGI does not prioritize RSI safety updates and changes especially in case of generic molecules
- The first need is the establishment and use of a PV database in India
- A well documented Schedule Y but not regulations or practices of the schedule
- The need to change the MAHs’ and RA’s mindset about only generating revenue and ignoring safety aspects
- The RA lacks manpower to diligently follow-up with the MAH and audit their practices and functioning
- There is still a confusion as to where do ADRs go and what is the action taken with them in India
Growth of PV systems in India
- Primarily rural population and lack of awareness is the bigger picture of the poor PV system in India
- However, a successful programme was run by the JSS medical college in collaboration with the National PV Program in Mysore wherein a survey was conducted as to the rise and pitfalls of drug safety in India
- Clinical trials are encouraged and conducted in bulk however ADR reporting is discouraging
- Case report presentations of actual statistics showing poor HCP response
- There were brief bursts and instances wherein we made progress or took an initiative to drive drug safety e.g. WHO started a drive in India
- The question arises whether HCPs are even aware of the peripheral centres located for ADR reporting
- Semi-voluntary actions and activities to educate the MAH sales staff or field personnel to educate people about the additional responsibility of ADR reporting
- Right of media and organisations can drive these practices further and build awareness
Dipti Kadam, Consultant Clinical Technology & System, DBMS Consulting
The presentation provided a detailed and complete IT perspective and uses of ARGUS PERSPECTIVE and ARGUS INSIGHT as effective tools for signal detection. The presentation also provided further information pertaining to the integration and alignment of these programmes/ software systems with other ORACLE applications or being used simultaneously.
- Initial highlight on signal detection: Past, present and Future
- ARGUS PERSPECTIVE features and technical applications were discussed: The software can be robustly customized to suit client needs and has a detailed programme to tackle all kinds of tasks
- ARGUS INSIGHT primarily aids in data mining and is an excellent tool for troubleshooting and advanced querying for specific requirements
- The Q&A session: ARGUS PERSPECTIVE as well as INSIGHT can be used with other Oracle applications such as AERS
Mahesh Malneedi, President and Co-Founder, MakroCare
Emerging Technologies and Strategies in drug safety evaluation
Use of database functions and advanced tools for signal detection were discussed
- Database functions and applications for case report, processing, submissions as well as safety reports
- Various challenges and strategies used for signal detection as well as tools and technologies required for case processing were highlighted
- An interesting point was the individual need for the various signal detection tools which depended upon the volumes of case reports and drugs an MAH received in a month. E.g. If the prerogative was to get from Pt A to Pt B, there were two ways of doing so: Either with a Nano or a Merc Benz. If the purpose was short term goals and immediate simplistic requirements to meet a target and perform basic tasks, ‘Nano’ software was ideal. However if one wants to add substance to the same prerogative combined with a long term forecast of requirements and anticipated volumes and complications, then investing in a ‘Benz’ software made sense.
- One point of debate was that if an MAH received <1000 to 2000 AEs per month, then the signal detection software was of not primary importance i.e. human detection was enough. This point was voraciously disagreed upon by the audience who reinforced that even one serious or life-threatening AE was sufficient for a signal
- The Q&A session raised concerns over the error window of a signal detection software over human detection. Ideally nothing can replace the human practice (manual detection). However the software was most ideal in terms of dealing with large volumes of case reports and AEs
Mr. Manoj Sharma, Group head, Panacea Biotech
Analyzing EU-PV regulations. The presentation was a revisit to EU regulations as well as brief outlook on the ROW (rest of the world) RA practices as well
- Detailed history and discussion on the EU-RA regulations, how they came into effect, their practices and a few upgrades since its inception
- Various milestones in the pharmaceutical sector which have shaped the ICH-GCP guidelines and various harmonization tools for clinical trials and safety monitoring
- Brief overview of the various sections and volumes of the ICH esp. Vol 9A and the definitions and constraints
- Rigorous penalties and fines levied for non-compliance or violations of any nature of the RA regulations by the MAH in their practices or process
- Q&A session: Parminder Kaur extensively corrected various aspects of the above discussion an even threw further light on the latest developments of the EU-RA as opposed to its historic regulations
PANEL DISCUSSION
Moderated by Milind Antani (Head Pharma Life Sciences Grp, Nishith Desai Associates)
Zoher Sihorwala, VP, Global RA, Dr. Reddy’s
Parminder Kaur, MD, RegPak BioPharma Consulting
Arun Bhatt, President, Clininvent Research
Points discussed primarily highlighted the poor state of Indian RA and DCGI vs. ROW:
- No well defined reporting, database tools or submissions systems available
- No RA vigilance
- The sad irony has come down to “We report and the DCGI collects”
- No actions are taken by the Indian RA post submission of reports i.e. no follow-up, penalties or queries. MAHs are content with the current state of affairs as their business runs smoothly with no probes. Consumer health, sadly, does not top the priority list
- Other than safety there are various aspects that have to be minutely scrutinized right from trials, to drug development, registration, pricing, packaging and marketing. One good e.g. an MAH marketed their drug in bottles with rubber stoppers. This was followed by mass cases of Pure Red Cell Aplasia (PRCA) which prompted the EMEA and FDA to recall the bulk of the drug and determine the cause. After extensive investigation it was discovered that leaching from the rubber stoppers into the medications (contamination) that were later consumed were responsible for the above disastrous chain of events
- India
- Awareness is well drafted in the form of drugs and cosmetic act as well as schedule Y however lack of enforcement of the same is the current state of the countries reporting system. Various points of concern also included:
o Poor infrastructure
o Poor use of training and applications in the field
o India
- There is hope but we have not yet breached the ‘Industry to Agency Handshake’
- Lack of data assimilation in India
- Despite a well written Schedule Y, the guidance’s are poorly explained or poorly understood
- Danger of spurious drugs, banned drugs, availability of prescription drugs as OTC products availability in open Indian market. E.g. gatifloxacin and nimesulide
- Conservative methods do not accurately capture all safety data and events
- The MAHs’ do not want to voluntarily raise an alarm concerning safety alerts practised in the ROW. They are content with building their revenue and the fact that no AEs are reported due to the poor reporting system
- Result: 100,000 deaths/year due to drugs alone
- E.g. during a diabetic trial (MAH, site and molecule confidential), the investigator identified liver disease as a serious adverse event. The same was aptly reported and subsequent moved on to a label change. However the process took nearly six months at the end of which none of the concerned authorities including the investigator were able to provide comprehensive reasoning for the said action. The end result: No label changes were made.
- There is awareness, but no drive, no compliance, and no ethics. The blame game continues however no takers for the onus of putting this process in motion.
DAY 2
INTRODUCTION
Mr. Fen Castro, Virtue Insight
Opening remarks by the chair for day 2.
Bhaswat S. Chakraborty, Sr. VP, R&D, Cadila Pharma
Data mining and signal detection.
- Fundamental concerns: Do we practice safety reporting and monitoring the same.
- FDA+EMEA: During drug development of a new entity or launch of an established molecule, the entire process needs and overview from a Risk Management point of view
- Premature approval of drugs will eventually lead to serious AEs and subsequent withdrawal from the market
- Market uptake and sales: Premature approvals, lack of safety profiles of relatively new molecules, direct consumer advertising and building good market sales and demand prior to a complete identified safety profile. These are the pitfalls of quick drug development which usually falls flat soon enough.
- Criteria and calculations of Toxic Disproportional ADR from the surplus data. E.g. estimation and causality assessment of bradycardia with propranolol
- Case study examples from the LAREB (Netherlands RA) database e.g. bupropion and seizures, olanzapine and thrombosis etc.
- Q&A session: Surplus data mining and unnecessary signal detection = opening Pandora’s box for several well established drugs in the market
- Extent of severity or safety concern is not highlighted
- Surplus of data itself needs to be qualitatively handled, sorted out and then put into application mode for signal detection. All aspects of the information is mostly not captured and segregated. Due to surplus, there is a need for refinement in data mining
- MAHs’ have primarily revenue and profit margins as a top priority by using their surplus data to comparatively present their drug to be as efficacious as the remaining generics (competitive entity) in the market
Dr. Prashanth BSB, Medical and Safety Expert (RA), Cipla
PV in focus
- Apart from battling illness is the ironic reality of battling drug side effects – which include ADRs, off-label use, recreational misuse, addiction, prescription errors, overdose etc.
- Healthcare for battling illnesses along with all that could go wrong with drugs in itself contributes heavily to the economy. >70% of these incidences are preventable but, sadly, not adhered to.
- A teratogenic drug like Thalidomide making 500 million sales/year following approval from FDA for various other indications e.g. leprosy
- Manipulation of safety data and presentation of surplus amounts of falsified data is another major issue from HCPs associated with trials and clinical data as well as from MAH.
- Practical problems and challenges: Non compliance, non-cooperation, repeat offenses and persistence. Premature conclusions and misreading signal thus causing unnecessary panic and anxiety
- Penalties, fines levied, prosecution and probably to the extent of marginal annual revenue/ community turnover revenue to be handed over to the RA or concerned authority (Presented country/ RA wise).
- Correction was made as to Nexium being an Astra Zeneca molecule NOT Sanofi Aventis
Simrat Sohal, Head PV, Eli Lily
Current standing in today’s PV market
- A revisit to the limitations of running PV process in India
- Of interest: DCGI is funded by world bank and NOT from our health ministry
- Poor quality of reporting, vague or no reporting whatsoever from HCPs. Hospitals refrain from information citing confidentiality clauses while overall approach is very restraint due to fear of being held liable
- The PSUR submissions in India
- Always better to over-report than under-report to the RA
- Sales personnel in a bid to market the product and meet targets tend to go overboard to the extent of providing off-label uses as indications of the drug. As discussed on Day 1, this in itself results in several ADRs and in rare cases – fatality
- Conditional marketing by EMEA and REMs by FDA for new molecular entities is a new and very effective step in putting forth safety data prior to approving the drug. This a limited period practice until the complete and safe establishment of the drug in the market
PANEL DISCUSSION
Moderated by S.K.Kulkarni (Emeritus Scientist & Prof. Pharmacology)
Zinobia Madan, Consultant, Clinical Research & Healthcare (Former associate VP, Wockhardt)
Simrat Sohal, Head PV, Eli Lily
Points discussed:
- Clinical trial safety and PMS is critical and of priority now. Especially in India
- Attention to safety should start prior to administering the study drug. Caution should be exercised and informed consent should be accurately carried out
- No incentives for shortcuts taken during trials where safety is concerned. In the long run unresolved serious events may harm commercial success of the molecule
- Open forum discussion on how to prioritize patient safety despite our limitations and lack of resources. DCGI alone cannot be blamed as its interests lie in the national MAH as well as MNCs. However basic tools of PV including IT infrastructure is completely NIL in our country.
- Points highlighted: How to train medical reps to sell the drug but at the same time ambiguously put forth reporting of any ‘concerns’ (adverse events).
- AEs cannot be coerced or requested from HCPs in case of spontaneous reporting
- Reluctance and unwillingness is the key point holding back the process
- Problems of attrition rates and lack of motivation is a waste of resources and the efforts gone into training and working the RA personnel
- Post marketing surveillance, if at all pursued, is primarily prescription driven than safety driven
Dr. Vishwas Sovani, MD, VP, Pharma delivery, TCS
Challenges in PV: Different sponsors, same drug
- The session was very similar to the ones heard on day 1 pertaining to the pitfalls of drug safety specifically in the Indian subcontinent.
- Revalidation of data duplication, lack of spontaneous reporting or ANY kind of reporting.
- A brief outline of the PV process was described: case processing, sources, submissions and review processes
- The situation of different sponsors and one drug: who takes the onus for safety and applied responsibilities
- The question lies in who i.e. MAH, CRO, Marketing partners, licensing partners or RA
- Each MAH and RA (regional) must take responsibility to ensure the safety and efficacy of the molecule not only at the trial stage but even at PMS stage
- PMS studies for safety as well as new indications must be indentified and carried out.
Dr. Siddharth Chachad, Medical and Safety Expert (RA), Cipla
Vol 9A guidelines for PV in the EU and key differences between US and Japan
The session was a revisit to EU guidelines and various detailed sections of Vol. 9A for PV and drug safety rules. Definitions of the same were highlighted during the session.
- The MAH guidelines and responsibilities w.r.t. registration, compliance, efficacy and safety of drugs put out by them in the market
- When the MAH outsources its processes or ties up with a licensing/marketing partner for its drugs, the primary onus lies on the MAH along with the supporting organizations
- EU-QPPV, a qualified medical professional, job description is defined as well. In many cases or in most severe cases, countries of the EU like France
- The QPPV must be based in EU and can be reported to from any part of the world. He/she is hired by and/or responsible only at the primary MAH stage and not for its partners
- MAH must provide details of the contractual agreements that it gets into, to the RA in order to outline who ACTUALLY carries out the processes
- Where safety reporting and scientific writing is concerned: Literature searches must entail the required databases as well as the articles written in the country’s local language for which the PSUR/DSUR submission is due.
- In Japan, safety data is collected as per ‘pockets’ or compilation of 1000+ patient pools who are followed up for years thereafter to ensure drug safety and efficacy. This data is then stored and put forth through signal detection.
- While in US-FDA black box warnings, dear doctor letters, RA alerts and FDA studies and analysis of cases are published for consumer as well as health professionals who use/prescribe the drug
PANEL DISCUSSION
Moderated by Simrat Sohal (Head PV, Eli Lily)
Dr. Siddharth Chachad, Medical and Safety Expert (RA), Cipla
Dr. Vishwas Sovani, MD, VP, Pharma delivery, TCS
This panel discussion marked the end of the conference. It also encouraged an open forum discussion rather than only the speakers/participants of the panel. End points and thoughts to leave behind were put forth:
- The overall conference was an eye-opener.
- There were open and deliberate remarks against the Indian RA (DCGI) which were supported by many delegates. However few begged to differ bringing forth the harsh reality of how easy it was to blame others while we (pharma companies) themselves did not seek to take full responsibility to put words to action
- The DCGI hands are slightly tied in trying to harmonize the national MAH as well as MNCs.
- The conference brought together people of various seniority, expertise and experiences. Many shared their personal experiences in terms of drug safety and the actions they took to make amends e.g. delayed submission or reports and proof of submission of electronic reports to DCGI
- Most areas of PV were covered but many stressed on common points which made this a repetitive session. What we already know was discussed and what we foresee was obvious
- The conference needed better time management as many views and points were cut-off mid way. The slides were rushed through and many experts did not get a chance to deliberate on important points that they wanted to make
- Participation was scanty especially with delegates and speakers leaving midway or through the second half of the day. This results in loss of expert opinions as well as a good audience to throw back ideas and questions. Loss of robust discussions and healthier debates
- The passion and pressure to improve the Indian scenario was apparent but now the question is; who will take responsibility to put this idea into motion?
- The conference became a commercial vs. academic endeavour
- A key point was that some personnel representing the DCGI should have been present at the conference to mark the comments as well as clarify many issues that the participants brought forth
- Another important point was the need for PV experts to educate their senior management and head of companies in order to move the ideas and processes of the table and into practice. Due to lack of this, companies do not actively realize and work on these ideas as they do not have a clear picture and gravity of the situation
- One must also understand the commercial viability of buying and using sophisticated and advanced IT tools in a country where we receive 1 case report/3 years
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Conference Testimonial:
"The conference was indeed a great experience.Both the presentations and the panel discussions/interactive sessions were very enlightening.I would surely like to attend the May clinical trial conference. I congratulate Virtue Insight for organizing a very useful and interesting Conference” - Dr. Varsha Narayanan from Elder Pharmaceuticals
I would say “PV 2010 was an opportunity to identify future clients as well as competitors along with an excellent learning platform”
Conference Presentations:
Please click here for conference presenations: http://www.slideshare.net/UntilROI/presentations
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