6^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sept 29-30, 2016 Orlando, USA

A regulatory-science driven clinical strategy is essential as part of today’s biopharmaceutical product early development planning.  A well-prepared regulatory strategy will align the proposed clinical development plan with business objectives, and pre-emptively identify challenges, as well as, proposed alternative/innovative approaches to new product development which leverage new standards for evidence generation supporting continuing development and global market authorization.  A regulatory strategy helps to define key issues/challenges to proactively discuss with Regulatory authorities and also defines key program milestones that are often considered business catalysts driving investor interest and financing. Most importantly, a timely, well-prepared and well-maintained regulatory strategy, with proactive and collaborative interaction with regulatory authorities, is often a differentiating factor for industry leaders bringing commercially successful and innovative products to market in today’s competitive marketplace. Regulatory strategy is a major component of successful biopharmaceutical product development. 

In early development, some companies view regulatory affairs as a function that is solely about compliance: preparing, submitting and maintaining applications; submitting adverse event reports; and coordinating routine communications with regulatory agencies. At Theorem, we feel this approach misses an important opportunity to use regulatory affairs strategically to reduce development costs, smooth the development path and improve post-approval marketing potential. Starting well before clinical trials are initiated, Theorem's strategic regulatory affairs (SRA) specialists do the work necessary to understand both the regulatory landscape and relevant precedents. Early regulatory guidance in these areas can build a framework for the overall development plan and help determine the fastest path to market that offers the greatest value. Strategic regulatory planning helps develop the scope of nonclinical, technical and clinical testing that will be required for registration.

For a trade whose business has sustained decades of respectable growth and margins. The novel Regulatory aspects include Novel Drug Delivery Systems, Medical Affairs, Active Pharmaceutical Ingredients, and Licensing in pharmaceutical production, packaging materials and pharmaceutical excipients. The new setting is testing the resilience and ingenuity of company corporations across the world. Some business models lack the ability to survive the approaching finish of the “blockbuster drug” era, even whereas resource constraints and sluggish innovation hinder the event of recent capabilities required to thrive in a very apace evolving market. These square measure so tumultuous times for the U.S. company trade. Succeeding in a very shifting world market and evolving tending landscape would require pharmaceutical corporations to adopt innovative business models targeted on novel ways, including: stress on “economic” outcomes: additional attention to the “economic value” of a medical care as a determinant for analysis funding and development. Personalised medicine: Shifting from “blockbuster drugs” to “personalized health and wellbeing.” Externalization and collaboration: additional reliance on external partners, academia, trade consortia and entrepreneurs for innovation, productivity and world growth. Globalization: fast growth to for countries for scientific talent and new markets. Health IT adoption: finance in new technologies to modify innovation and drive efficiencies. Novel Regulatory strategies include both Nano therapeutics and biotech therapeutics.

Pharmaceutical and drug registration is also becoming more regulated throughout Asia. Indeed, the requirements for local drug clinical trials are becoming more prevalent in some countries like Korea and Taiwan. With innovation key to growth in emerging markets, regulatory policies are becoming more open and supportive of innovative drugs. There are several challenges around pharmacovigilance in Asia. India plans to begin interacting with international pharmacovigilance bodies in 2013/14  by which time it will be among the biggest pharmaceutical markets in the world before creating an Asia-Pacific centre of excellence for pharmacovigilance in 2014/15.The complicated regulatory landscape in Asia can be a barrier to success for foreign companies that do not have the experience or resources that are essential to overcome the obstacles in countries such as China, India, Japan, Korea and Taiwan

Guidelines on clinical trials for import and manufacture of new drug were introduced in the Drugs and Cosmetics Rules as Schedule Y in 1998. This heralded the entry of clinical trials organization like Quintiles into India and encouraged the pharmaceutical industry to conduct phase III trials. Ethical Guidelines for Biomedical Research on Human subjects was brought by Indian Council of Medical Research (ICMR) in 2000. Good Clinical Practices were adopted by India in 2001 by Central Drugs Standard Control Organization (CDSCO). The National Institute of Medical Statistics of ICMR also set up a clinical trails registry in 2009. A new amendment to the Drugs & Cosmetics Act is seeking to replace the Central Drugs & Services Control Organization (CDSCO) with the Central Drug Authority (CDA) comprising of Drugs Controller General of India as the chairman and five other members. Ten departments will be controlled by the authority include regulatory affairs, imports, new drugs, biotech products, pharmacovigilance, medical devices and diagnostics, organizational services, training, quality control and legal & consumer affairs. Moreover new bill for regulation of medical devices industry is also in the gambit. Medical Devices Regulatory authority is a body; government is yet to implement to regulate the ballooning medical devices industry whose products are largely approved in other countries and eventually finds entry into Indian market.

Over the years, the European nuclear medicine/radiopharmaceuticals market has witnessed various advancements in radiopharmaceuticals. The European radiopharmaceuticals market is witnessing growth owing to an increasing number of radioisotope approvals for different clinical indications. Tc-99m and F-18 radioisotopes are estimated to contribute the highest to the European nuclear medicine diagnostic market in 2015, whereas Ra-223, I-131 and Y-90 ensured their leading position in the therapeutic market. The European nuclear medicine/radiopharmaceuticals market is expected to reach $1.62 Billion by 2020 from $1.09 Billion in 2015, growing at a CAGR of 8.2% from 2015 to 2020.

The regulatory landscape has continued to evolve in response to product safety, regulatory compliance, new technologies, improved understanding of disease states, stakeholder and customer needs and global imperatives, with new and increasing regulations, regulatory guidance and oversight. The Global regulatory affairs group and the regulatory professionals in the biopharmaceutical industry occupy a central and pivotal role to all the functional groups. The regulatory team is charged with a strong leadership role that ensures compliance with regulations and enables understanding and interpretation of the dynamic regulatory landscape, while creating opportunities in the highly-regulated and complex environment. The challenging landscape is largely a result of the success of the biopharmaceutical industry in delivering medical therapies for many disease states, safety catastrophes from use of products post-approval; and product quality compliance issues. These have sharpened regulatory authorities focus on product benefit/risk profiles and related stakeholders’ views on cost effectiveness and patient access. The regulatory professional has to be equipped and poised to effectively guide the organization to success with a credible voice, informed strategic guidance and objective evaluation.

The global Active Pharmaceutical Ingredients Market is expected to reach USD 205.51 billion by 2020 from USD 150 billion in 2015, at a CAGR of 6.5% during the forecast period. Factors such as the increasing incidence of life style and age related diseases, Increasing prevalence of cancer across the world, Technological advancements in the APIs Manufacturing, Emerging markets for biosimilar and increasing scope for Highly potent active ingredients are driving market growth. On the other hand, stringent regulatory requirements and global economic recession may restrict market growth.October 2015   $ 4650 selected

A biopharmaceutical, also known as a biologic medical product or biologic, is any medicinal product manufactured in, extracted from, or semi synthesized from biological sources. Different from chemically synthesized pharmaceuticals, they include vaccines, blood, or blood components, allergenic, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They are isolated from natural sources—human, animal, or microorganism. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid–based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

Therapies based on biologic products have been a disruptive innovation in the pharmaceutical industry due to their success in targeting previously unmet medical needs. Sales of biologics reached 142 billion USD in 2011, equivalent to 19% of the global biopharmaceutical market in terms of revenue  with more than a third of this value (37.6%) captured by the top ten selling biologic products. The size of the market and its evolution from 2004 to 2011 is shown in  highlighting the top ten selling brands: Humira, Enbrel, Remicade, Rituxan, Avastin, Lantus, Herceptin, NovoLog, Neulasta and Lucentis.

Drug business is one in every of the country’s most significant economic engines, commerce $15 billion in merchandise annually and a few of its factories area unit foremost. The federal agency has developed a series of tips for developing GXP (which includes GCP, GLP and GMP regulations) that shield each the life sciences business and also the customers they serve. So as to help FDA-regulated firms, master control offers associate in integrated quality and compliance management code that assures GLP, GCP and GMP rules compliance. Industry practices is also part of quality risk management system, Pharma Regulatory Affairs, Audits and inspections, validation methods (process validation and analytical validation), Qualification, validation, calibration, maintenance, risk analysis Drug Safety and Good pharmacovigilance practices. 

Good manufacturing practice (GMP) is a system for ensuring that the products are consistently produced and controlled as per the quality standards. GMP must be followed by every pharmaceutical company ensuring the quality of life of the people consuming it. GMP plays a key role in providing therapeutic solutions at a very affordable cost.

 As per the current statistics, the country’s pharmaceuticals industry accounts for about 2.4% of the global pharma industry by value and 10% by volume. The industry revenues are also expected to expand and grow at a CAGR of 12.1% during 2012-20 and reach USD 45 Billion. Currently, the healthcare sector in India is USD 65 billion and is expected to grow to USD 250 Billion by 2020.

In the EU, a biological meditative product is one amongst the active substance(s) created from or extracted from a biological (living) system, and needs, additionally to physico-chemical testing, biological testing for full characterisation. The characterisation of a biological medicative product could be a combination of testing the active substance and therefore the final medicative product at the side of the assembly method and its management. Principal ideas of Intellectual Property Management (IPM) and its importance as a spur to human power and therefore the advancement of economic and social development. It additionally provides rationalization on the event Associate in implementation of an IPM strategy together with the management of material possession (IP) in an internet setting. Scientific discipline law usually grants the author of associate in intellectual creation exclusive rights for exploiting and cashing in on their creation. Scientific discipline protection is meant to stimulate the power of the human mind for the advantage of all by making certain that profits derived from exploiting a creation benefit the creator. This may encourage activity and permit investors in analysis and development a good come on their investment. Scientific discipline confers on people, enterprises or alternative entities the correct to exclude others from the employment of their creations safety and quality regulation in labelling. Consequently, material possession rights (IPRs) could have an on the spot Associate in substantial impact on trade because the owner of an IPR could - through the social control of such a right - forestall the manufacture, use or sale of a product which includes the IPR. For this reason management over the intangible (IPR) connotes management of the merchandise and markets. Scientific discipline protection encourages the publication, distribution and speech act of the creation to the general public, instead of keeping it secret whereas at identical time encouraging industrial enterprises to pick out inventive works for exploitation. Material possession legal titles relates to the acquisition and use of a variety of rights covering completely different form of creations. Patents in the pharmaceutical industry include both legal and ethical issues.

Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies. More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400 As per cabinet decision in June 2010 in Japan amended a new policy i.e., Health power strategy through “Life Innovation” and expenditure spent on each drug was $450 million 

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. Global regulatory affairs groups in industry provide worldwide, strategic leadership in and comprehensive direction of the government regulatory requirements for product introduction and commercialization, utilizing regulatory knowledge to ensure compliance and regulatory intelligence and create opportunities in a highly-regulated environment. 

The U.S. general anaesthesia drugs market is poised to reach ~USD 2.0 Billion by 2020 from USD 1.6 Billion in 2015, at a CAGR of 3.8% from 2015 to 2020. Factors such as rapid rise in aging population, rising prevalence of cardiovascular and respiratory system-related diseases, and rising number of emergency surgeries are key factors driving the growth of the U.S. general anaesthesia drugs market. However, side effects associated with ketamine usage (such as elevation in blood pressure and heart rate, amnesia, respiratory depression, and hallucinations), regulatory issues, and lower compliance rates in comparison with other aesthetic drugs are likely to restrain the growth of this market.

FDA laws and rules needed to with success develop and commercially market medical devices within the us. Topics include: product development/approval method, post-market controls, state and federal website inspections, social control activities, and suggestions for operating proactively with the authority. The term medical devices or Medical Devices Regulatory Affairs covers an enormous varies of kit, from straightforward tongue depressors to haemodialysis machines. Like medicines and different health technologies, they're essential for patient care – at the side, at the agricultural health clinic or at the massive, specialised hospital. Makers should list their devices with the authority. Institutions needed to list their devices include: makers, contract makers that commercially distribute the device, contract sterilizers that commercially distribute the device, repackages, Medical device reporting and re-labellers, specification developers, reprocesses single-use devices, remanufacturer, makers of accessories and parts oversubscribed on to the top user, U.S. makers of "export only" devices. Medical device rules includes: Medical device reportage, Governmental regulation of medical devices, world Harmonization Task Force (GHTF), optimizing the utilization of Pharmaceutical Regulatory Affairs.

The global top 10 medical device technologies market is expected to reach USD 428.97 Billion by 2020, at a CAGR of 5.5% from 2015 to 2020. Growth in the global top 10 medical device technologies market is mainly driven by factors such as the rising prevalence of chronic diseases and related increase in disability-adjusted life years (DALYs), technological advancements in medical devices, and growing aging population. Moreover, increasing investments from government bodies and private players in healthcare sectors in emerging economies and increasing focus of key players on emerging countries are creating new growth opportunities for this market. However, uncertainty in reimbursement and excise tax on medical devices in the U.S. are restraining the growth of the market.

Most regulatory professionals focus their careers on the regulations of a single country or region such as the US or EU. In order for a global regulatory leader to be truly effective, it is critical to understand the key regulatory issues in all major markets and to apply this knowledge to a global regulatory strategy. Communication between health authorities is increasing, making it vitally important that regulatory leaders develop their strategies with a global view. In addition, current trends in the pharmaceutical industry indicate that more and more companies are expanding their global presence to benefit from the explosive growth being projected in the emerging markets. This course will allow participants to understand key requirements for the development and execution of a global regulatory strategy by identifying the strategic and tactical aspects of pharmaceutical development in the US, EU and emerging markets.  Course participants will have the opportunity to apply learning objectives in a hands-on workshop.

The global Active Pharmaceutical Ingredients Market is expected to reach USD 205.51 billion by 2020 from USD 150 billion in 2015, at a CAGR of 6.5% during the forecast period. Factors such as the increasing incidence of life style and age related diseases, Increasing prevalence of cancer across the world, Technological advancements in the APIs Manufacturing, Emerging markets for biosimilar and increasing scope for Highly potent active ingredients are driving market growth. On the other hand, stringent regulatory requirements and global economic recession may restrict market growth.October 2015   $ 4650 selected

The area unit variety of motives for extending the merchandise development outside of the mature, developed economies (e.g. the EU and therefore the US) and most of them have faith in the high population and market potential of rising markets. FDA guidance for clinical investigations and Pharmaceutical development goes a lot of and a lot of international within the direction of rising markets that tend to supply solutions for the patient achievement and overall development prices and timelines. Some reasons for this growing trend area unit result of the inevitable “patent cliff” that forces firms to any extend their reach and develop any. It's clear that rising markets supply nice market and population potential however at constant time cause sure challenges, as well as moral, GCP. Licensing in pharmaceutical production is mandatory step for pharmaceutical products. Regulatory matters is definitely acknowledged by the complete pharmaceutical community and authorities try to develop a cooperative model for harmonizing the Regulatory necessities across the regions so as to ease the world pharmaceutical development (Active Pharmaceutical Ingredients, Pharmaceutical excipients and Packaging materials) and acceptance of knowledge. Having a neighbourhood experience will highlight these challenges and necessities which might facilitate decide however international the corporate extremely desires to travel. Generally the proper Regulatory info at the proper time may be a crucial issue for reaching proper choices since it looks that pharmaceutical firms have chance to decide on their development direction however no chance to bypass the need for selection.

Over the years, the European nuclear medicine/radiopharmaceuticals market has witnessed various advancements in radiopharmaceuticals. The European radiopharmaceuticals market is witnessing growth owing to an increasing number of radioisotope approvals for different clinical indications. Tc-99m and F-18 radioisotopes are estimated to contribute the highest to the European nuclear medicine diagnostic market in 2015, whereas Ra-223, I-131 and Y-90 ensured their leading position in the therapeutic market. The European nuclear medicine/radiopharmaceuticals market is expected to reach $1.62 Billion by 2020 from $1.09 Billion in 2015, growing at a CAGR of 8.2% from 2015 to 2020.

A platform aimed to connect Entrepreneurs, Proposers and the Investors worldwide. It's intended to create and facilitate the most optimized and viable meeting place for engaging people in global business discussions, evaluation and execution of promising business ideas. An investor could be able to find out the highest potential investment opportunities globally, which provide good return on investment. For entrepreneurs, this would be an ideal place to find out suitable investors and partners to start and/or expand their business. Thus it is a perfect place to connect Entrepreneurs, Business Owners, Early Stage Companies and Established Corporates with National or International Investors, Corporate Investors and Potential Business Partners.

Pharmaceutical industry is also called as “sleeping giant”. This industry is world’s largest industry in terms of revenues and investments. Its world’s recession proof sector and is highly organized and regulated. Indian pharmaceutical industry is third largest pharmaceutical market in terms of volume and fourteenth in terms of value. Currently, Indian pharma industry is growing at rate of 15% compound annual growth rate (Facts as per Market Line Advantage Report 2014). Different segments such as clinical research, contract research, contract manufacturing and project management are having very high demand now a day