<p>The clinical trial market in India looks very lucrative. India has several unique features for being a hot spot for the clinical trial market. As a signatory to the World Trade Organization agreements, India is looked upon as a favorable destination for conducting global clinical trials. There are many opportunities and challenges for conducting global clinical trials in India. In a majority of cases, these drugs are aimed at providing answers to unmet medical needs.</p><p>Clinical research is important not only for developing medicines for emerging health concerns (such as antibiotic resistant pathogens, H1N1, Dengue, , etc.) also for finding safe and better medicines for entrenched diseases such as HIV, Malaria, tuberculosis (especially drug resistant TB) Diabetes, Hypertension, Cancer, heart failure etc. India, with its large patient population, and limited resource has significant unfilled health needs. We should make the newest and best treatment option to be avail to the population and to the patient’s globally. For this, India must proactively take part in conducting clinical research (“Research for India”) and assume leadership role globally (“made for the world”). As we are operating in a new regulatory and operational environment, we have a great task ahead of us – strengthening the sites, Investigators, Ethics Committees and empowering the patient who is the center of the clinical research enterprise.</p><p>Our world is changing as we focus more on biotech, personalized medicine, biomarkers, rare diseases and orphan indications. With this comes many challenges that we have only rarely faced in the past. As we focus more on the patient, stability and formulation hurdles arise. There is a growing need for forecasting and planning improvements and temperature control of distribution into truly emerging markets. It is essential we come together to learn not only how our colleagues are handling these issues, but are how they are ingeniously overcoming them. </p><p>It gives us immense pleasure in welcoming you to the 7th Annual Clinical Trials Summit 2016. I wish and pray that all our efforts will be beneficial to our industries and to our country at large<strong> </strong></p><p> </p><p><strong><strong>KEY THEMES DISCUSSED IN THIS CONFERENCE:-</strong></strong> </p><ul><li>Insights, Implications, Impact and Implementation of risk management in trial conduct</li><li>Tracking returns, Reconciliation & Destruction to manage costs</li><li>Reduce significant costs through successful embedding of modulation and simulation in the clinical supply chain</li><li>Underlining the benefits and implications of drug pooling in the clinical supply chain</li><li>Marketing for your clinical research practice</li><li>Insurance coverage: How the ACA changed access to clinical trials</li><li>Regulatory updates and Good Clinical Practice (GCP) auditing techniques</li><li>Developing a standardized tool to improve patient comprehension during consent</li><li>Insight and practical tips on how to work with all payer types to obtain coverage of clinical trial routine costs.</li><li>ACA, Medicare, Medicaid and state requirements regarding coverage of clinical trials.</li><li>Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practices</li><li>Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients</li><li>Overcoming challenges faced in regulatory approval processes – obtaining drug/ clinical supplies import and export licenses in Asia</li><li>Margin of safety: Identifying ideal clinical sites and strategizing patient recruitment and clinical sites management in India to develop appropriate clinical studies</li><li>Next generations of clinical trials – How big will the market be?</li><li>Be part of a major networking opportunity</li></ul><p> </p><p><strong>WHO SHOULD ATTEND:-</strong></p><p><strong>CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of:<br /></strong></p><ul><li>Clinical Research & Development</li><li>Clinical Research Services</li><li>Clinical Operations</li><li>Clinical Data Management</li><li>Clinical IT</li><li>Clinical Trials</li><li>Medical Affairs</li><li>Regulatory Affairs</li><li>Compliance</li><li>Quality control / Assurance/GCP</li><li>Clinical Study Design</li><li>Safety Surveillance</li><li>Subject Recruitment</li><li>E-Clinical Systems</li></ul>
<p><strong>7th Annual Clinical Trials Summit 2016 - “A critical guide for successfully conducting clinical trials”</strong> - Get more from the event, with a <strong>broader scope bringing the whole communications value chain together</strong>. Enjoy and make the best out of our <strong>dedicated networking drinks time, meet the leading international vendors</strong> expand your knowledge of the latest business models and strategies in the high-level conference.</p>
<p><strong>NOW SOURCE COMPARATORS / BIOSIMILARS WITH CONFIDENCE FROM INDIA </strong>- Mumbai, India - February 8, 2016</p><p>Sourcing Comparators / Biosimilars have always been an Achilles heel in any Clinical trial.
These seeming simple products are the “Check Nuts” that can make the entire trial go haywire if supply is delayed. The challenge of sourcing Comparators / Biosimilars gets compounded specially for large multi centric trials.</p><p>Traditional source markets such as US / EU have seen increased regulations and tightening of supply chain thereby severely constricting supply. Each vial or pack can now be tracked by the manufacturer / brand owner through the entire supply chain under the new barcoding systems. Thereby making it extremely difficult to divert stock for Trials without alerting the innovator or brand owners.</p><p>Emerging markets such as India have always posed a challenge due concerns about similarly or equivalence with the innovator sold in US / EU markets.</p><p>One company stands out as a pioneer in Clinical trial supplies from India and is working to change this perception by putting out facts in the open. GNH India has been successfully supplying to a number of Global trials with comparator / biosimilars sourced from the Indian market.</p><p><strong>We spoke to Dr. Piyush Gupta, MBBS, MBA - Associate Director - Business Development at GNH.</strong></p><p>Dr. Gupta says “There’s a mind set at play here. People think that if a product / brand is being sold in India it’s going to of poor quality and standard. This is absolutely untrue in the pharma business. No manufacturer is going to risk is reputation, brand and most importantly violate laws and sell substandard products in India”.</p><p>To prove his point Dr. Gupta say : CoPP (Certificate of Pharmaceutical Products) an essential requirement to register any new drug in any country including India is the key.
At the time of registering (introducing) a new product in India the Innovator / Brand has to provide a CoPP from the FDA (Food and Drug Administration) of the Originating Country (Country where the product is manufactured).</p><p>A CoPP issued by FDA of Origin country essentially states that product being supplied (exported) is the exact same in specification as the one being in country of Origin.
Without this CoPP from FDA of Origin, FDA of importing country will not allow registration of a brand / innovator / Generic in importing country.</p><p>This fact is very well known to the manufacturers but regretfully not to the Clinical trial industry, which largely runs on Out sourced contracts.</p><p>GNH India is an Award winning Global full-line wholesaler Audited by SGS France for WHO cGSDP practise and carries over 135,000 product lines, shipping to over 180 countries wold wide.</p>