Mumbai, April 08, 2015 – In the early 1980s, talking about the worldwide pharmaceutical market really meant the U.S,Japan, and Europe, which comprised the bulk of total sales, with the rest of the world (ROW)thrown in somewhat as an afterthought. Today, ROW is a term of the past, and with increasing speed, the concepts have changed from “developing” to “emerging” and now to “growth “markets, with China already today having become major market, the number two global pharmaceutical market.
According to reports , By 2016, it’s expected that the four BRIC nations (Brazil, Russia, India and China) will all be in the top 10 global pharmaceutical markets and will constitute 30 percent of the top 10 market, spending $244–$284 billion. Asia has a population of around 4.3 billion and is home to about 60 percent of the world’s population. China alone has a population of approximately 1.3 billion, which is three-to fourfold bigger than Europe or the U.S. Adding in the other developing markets, such as those in Latin America, this makes for a huge potential market for the pharmaceutical industry, and one important not to miss. The growth markets popularly include Brazil, Russia, India, China – the BRICs however Mexico, South Korea, and Turkey are now added to BRICs to be known as the BRIC-MST countries. Victoria Andalibi General Director and Founder Global Parma Moscow will be focusing on regulatory environment in Russian market. She is key note speaker at International conference on emerging market organized by Alliance India. This event is scheduled on the 9th & 10th of April 2015 in Mumbai.Various pharmaceutical companies would be present at the event.
In terms of the submission format, countries are beginning to move closer to the international submission template (eCTD — electronic common technical document). Similarly, the trend is toward more harmonization in legal frameworks among the countries. For example, China’s regulatory processes are evolving, creating a framework that is more closely aligned to the U.S. and European legislation and in both South Korea and China, and the regulatory agency has been raised to the ministry level.
Even as the guidelines are becoming better harmonized, some very specic local requirements are becoming signicant enough to shape the entire worldwide strategy. These can be as simple as the need for translations, or as complex as the structure of the entire clinical trials.Ms. Hasumati Rahalkar the chairperson of the event and would be speaking on super generics on emerging market which is very important for pharma industries
The Key Topics for the Conference are:
1. Regulatory Challenges & Success Models in BRICs.
2. Regulatory updates and industry case studies for successful product registration in South Africa.
3. Regulatory updates and practical advice for market access in GCC and MENA markets.
4. Insight into the regulatory environment and market entry in Brazil and Mexico.
5. Practical advice for market access in Turkey.
6. Regulatory requirements for bio similar registration in Emerging Markets.
7. PIC/s Audit and its acceptance across countries.
8. Super generics in Emerging Markets.
9. New Drug Delivery system and regulatory requirements.
10. How to write regional CTDs i.e. ASEAN, AFRICA, GCC with special emphasis on module 4 &5.
11. DMF Content & requirements in Emerging Markets.
12. Possibility to harmonize labeling for Emerging Markets.
13. Regulatory Compliances or Product Life Cycle
14. Management for Emerging Markets.
15. WHO PQP submission and approval procedure.
16. Regulatory challenges in Russia updates on 2014-2015.
17. Regulatory Challenges & Success Models in China.
18. India regulatory environment and latest updates.
KEY TOPICS WILL BE ADRESSED BY RESPECTED DIGNITAURIES FROM LEADING ORGANISATION; For Instances’: NITIN GAIKWAD , General Manager of Lupin Limited, RAHUL GUPTA GM Corp Regulatory Affair of Primal Enterprises Limited , PRASANNA KUMAR Dir Regulatory Affair of Dr.Reddy’s Laboratories LTD ,SUCHITRA TIWARI Head Regulatory of RPG Life Sciences and many more.
Alliance India brings together eminent experts from top Pharmaceutical Companies who will discuss and debate of the hot topics pertaining to Regulatory Scenario for Pharmaceuticals in growth markets. Here are some of the Key Topics that are of relevance to Global Pharma Industry. The Regulatory session are based on hot topic “Regulatory Affairs in Emerging Markets”.
CCI Newswire
