I am writing on behalf of Indian Pharmaceutical Association (IPA). We would be pleased to welcome you as the speaker to attend Asia Pacific Pharmaceutical Science Summit Forum(APPSF)on Jan. 9-10, 2019 in Shanghai, China and give a 40-minute talk on: 1. New Drug Development Pathways in China 2. Generic Drugs: Research, Development and Regulatory Strategy Visions 3. Quality by Design -Concept and Implementation 4. Analytical Application and Biosimilar Introduction. We have watched your interview on the Internet and read your articles, and we would like to meet you and learn more about how you lead the pharmaceutical industry as well as the market to the road of innovation.
It is an honor and privilege to invite you to participate in our forum. We believe that your topic to pharmaceutics awareness is unparalleled, and are looking forward to hearing you speak on the forum. We will cover your expenses incurred during the conference for——travel and accommodation.
Thank you for considering our invitation. I hope to receive a positive reply from you before 11:59 p.m. on Nov. 9, 2018. If you have any questions, I can be reached anytime at yangchao@sjbmcc.com.
Kind regards,
Yours sincerely,
Indian Pharmaceutical Association (IPA)
Organizing Committee of Asia Pacific Pharmaceutical Science Summit Forum(APPSF)
Time: Jan. 9-10, 2019
Venue: Sheraton Shanghai Hongkou Hotel
Host: Indian Pharmaceutical Association (IPA)
SHENGJIE(Shanghai) Business Management & Consulting Co., Ltd
Co-organizers: Pharmacy Council of India (PCI)
Director: Chamber of Informatic Industry Commerce, Shanghai Federation of Industry and Commerce (SFIC)
Supporters: Health Branch of Shanghai Federation of Industry and Commerce
ACPI KSPOR
Acharya Institutes
JSS Academy of Higher Education & Research
Media Partners: People.com.cn, Xinhua Net, The Paper, Eastday, Tencent, DXY, PHARMCUBE, Yaozhi, PharmFuture etc.
Forum Introduction: Asia-pacific Alliance, To improve Health Care Industry!
Domestic pharmaceutical companies face serious challenges now.
Join APPSF for the next breakthrough.
On Innovate Drugs
The current size of Chinese anti-tumor market is about 140 billion yuan. One third of the market is covered by the imported drugs. Drugs with the best curative effect are mostly imported. Although China has become the second largest medical and pharmaceutical market in the world, its proportion of innovative drugs with independent intellectual property rights is only 18%, far below the level of the United States, Europe and Japan.
On Generic Drugs
The global generic drugs market was valued at around US$ 244.5 Billion in 2017, growing at a compound annual growth rate (CAGR) of around 8% during 2010-2017 and Is expected to reach approximately USD 380.60 billion by 2021, expected growing at a CAGR of around 10.8 % between 2016 and 2021. FDA’s 2018 Proposal to Harmonize Standards for Generic Drugs, with such initiatives from Global regulatory bodies, propels the future of producing generic drug and makes the Generic Drug industry a high potential market and reason for generating more revenue for generic drugs Pharmaceutical industry. Thus, the current conference focuses on providing information to understand current global regulatory requirement for generic drug development and making your success path easy for contribution for development of quality medicine and treatment in cost effective way.
On QbD
Quality by Design (QbD) continues to be a hot topic across the life science industries, and as evidenced by the widespread adoption of QbD among manufacturers, there is no question about its benefits. As the pharma sector moves to implement pharmaceutical QbD, regulatory bodies such as the FDA work provide a common understanding of key concepts, terminology and expectations. This conference focuses on reviewing the current understanding of concepts of pharmaceutical QbD and its implementation.
On Biosimilar:
Biosimilars are often confused with generic drugs—but they are not the same. Unlike generics, the FDA requires a biosimilar to be highly similar, but not identical to the existing biologic medicine, which is referred to as a "reference product”. Biopharmaceuticals accounted for nearly 25% of the global pharmaceutical market revenues from marketed drugs (~$1,100 billion) in 2016. To add to this, the patent expiry of the leading 10 biologic drugs represents a massive $70 billion opportunity for pharma companies over the period 2015 - 2020. Please join APPSF to learn more about the future game changer – Biosimilar.
We look forward to having professionals from related industries worldwide to attend this Asia Pacific Pharmaceutical Science Summit Forum(APPSF). With the industry insight and problem-oriented strategy, we will lead the pharmaceutical industry and market to the road of innovation. It would be great to have this forum in January. Let’s create and develop together.
Schedule
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Jan.9 Wednesday |
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08:30-09:00 |
Admission |
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09:00-12:30 |
New Drug Development Pathways in China (Opening Ceremony) |
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12:30-13:30 |
Lunch |
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13:30-16:40 |
Generic Drugs: Research, Development and Regulatory Strategy Visions |
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16:40-17:00 |
Appointment Ceremony for Honorary President and Advisory panel |
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Jan.10 Thursday |
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08:30-09:00 |
Entrance |
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09:00-12:30 |
Quality by Design - Concept and Implementation |
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12:30-13:30 |
Lunch |
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13:30-17:00 |
Analytical Application and Biosimilar Introduction |
Agenda
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Day 1 |
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New Drug Development Pathways in China (Opening Ceremony) |
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09:00-12:30 on Jan.9 The Banquet Hall on the Third Floor |
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Host speaker: Mr. Haihong Jin, Secretary-General, Chamber of Informatic Industry Commerce |
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08:30-09:00 |
Admission |
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09:00-09:10 |
Leader’s Oration |
Dr. B Suresh, President, Pharmacy Council of India Mr. Haihong Jin, Secretary-General, Chamber of Informatic Industry Commerce |
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09:10-09:50 |
Importance of Pharmacovigilance in Cancer Therapy |
Dr. B Suresh, President, Pharmacy Council of India |
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09:50-10:30 |
Breaking the cultural barrier between India and China to improve the pharmaceutical industry |
Dr. T. V. Narayana, President, Indian Pharmaceutical Association |
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10:30-11:10 |
China Drug Development Process - New Regulatory Reforms to Overcome the Barriers. |
Dr. Bill Wei, Founder and CEO Innovaco Pharmarceutical Inc., China |
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11:10-11:50 |
The Market Authorization Holder System(MAH)-Detail Overview |
Mei Hao, VP, Quality Assurance, STA, China 【Draft】 |
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11:50-12:30 |
Safety of Clinical Treatment Efficacy Based on PD-1/L1 or Pharmacovigilance and its importance :Anticancer Application |
Anantha Naik, Director, Amity Institute of Pharmacy, Gwalior, India. |
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12:30-13:30 |
Lunch |
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Generic Drugs: Research, Development and Regulatory Strategy Visions |
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13:30-17:00 on Jan.9 The Banquet Hall on the Third Floor |
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Host speaker: Dr. B Suresh, President, Pharmacy Council of India |
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13:30-14:30 |
Regulatory Challenge and Approach for Global Generic Drug Develop-ment: Understanding Current Guidelines and Strategy (China, US, UK, Japan, Australia, and Canada) |
Dr. Raghunandan Venkatram Huralihalli, Founder of Chief Technical Consultant, RC2 Pharma Solutions, India. |
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14:30-15:20 |
Challenges and Opportunities of Generic Drugs in Chinese Market: Current Regulatory Overview |
CNDA【Draft】 |
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15:20-16:00 |
Development of Oral Tablets – A Design Strategy |
Harish K Jain, Director, Embiotic Laboratories (P) LTD Secretary, Karanataka (Provincial) Drug Manufacturing Association. |
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16:00-16:40 |
Electronic Regulatory Submissions in eCTD Format – Understanding and Implementation. |
Indian Pharmaceutical Association |
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16:40-17:00 |
Appointment Ceremony for Honorary President and Advisory Panel |
Organizer |
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Day 2 |
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Quality by Design - Concept and Implementation |
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09:00-12:30 on Jan.10 The Banquet Hall on the Third Floor |
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Host speaker/Chairperson: Dr. Premnath Shenoy |
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08:30-09:00 |
Entrance |
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09:00-10:00 |
Importance of QbD and its Approach in Pharmaceutical Industry - Regulatory Overview (USFDA, EU-EMEA, PMDA & ICH) |
Dr. Bhupinder Singh Bhoop, Professor, University Institute of Pharmaceutical Sciences, Panjab, Chandigarh, India |
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10:00-10:50 |
Application and Implementation of QbD Design in Generic Drug Development - Solid and Semi Solid Overview |
Dr. Bhupinder Singh Bhoop, Professor, University Institute of Pharmaceutical Sciences, Panjab, Chandigarh, India (Team) |
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10:50-11:40 |
Application of QbD in Analytical Research and Development |
Dr. Bhupinder Singh Bhoop, Professor, University Institute of Pharmaceutical Sciences, Panjab, Chandigarh, India (Team) |
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11:40-12:30 |
Terminology, Statical tools and Models used for implementation of QbD |
Dr Shivang Chaudhary, Chief Knowledge Officer (CKO) & Global Head Quality by Design (Formulation & Process Development), QbD Expert™ Ahmedabad, India. |
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12:30-13:00 |
Lunch |
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Analytical Application and Biosimilar Introduction |
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13:30-17:00 on Jan.10 The Banquet Hall on the Third Floor |
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Host speaker: Harish K Jain |
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13:30-14:10 |
Recent Developments and Approaches in Pharmaceutical Analysis: Method Development, Qualification and Validation |
WuXi AppTec【Draft】 |
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14:10-14:50 |
Global Regulatory Challenges and Consideration for impurity characterization for: Heavy Metals, Residual solvents and genotoxic. |
Pharmacy Council of India |
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14:50-15:30 |
Introduction to Bio analytics and Advances in Bio analytics |
Dr. V. V. Ramireddy, Global Director and Technical Operations, National Chromatography Inco. (Bangalore and USA) |
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15:30-16:10 |
Role and Importance of International Pharmacopoeia and their control on Pharmaceutical Preparation. |
USP【Draft】 |
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16:10-17:00 |
Biosimilar Medicine: Global Scenario and Race in China (Future Game Changer). |
Dr. Premnath Shenoy, Regulatory Director, AstraZeneca. |
More guest speakers are coming in, and the final schedule is subject to the actual arrangement of the conference.
The Indian Pharmaceutical Association (IPA) founded in 1939, is the oldest premier association of pharmaceutical professionals in India, with a member base of over 13,000, spread across the length and breadth of the nation. IPA operates in India through 20 state branches and more than 46 local branches. The members represent various facets of pharmaceutical profession viz., industry, regulatory, community and hospital pharmacy practices and education.
As a member of the Drug Technical Advisory Board, India, IPA is actively involved in advising the government on matters of professional importance. IPA is affiliated with international pharma associations like FIP, FAPA, CPA, AAPS, AAiPS and is working with international bodies such as WHO and WHPA for carrying out various collaborative professional activities that include organizing training programmes for professionals from industry, academics, regulatory and practice.
IPA makes representations to the authorities on matters of professional interest and works constantly towards upgrading the standards of pharmacy professional services offered by the pharmacists. IPA’s major objective is to position pharmacists as one of the important healthcare providers in our country.
Jan 09
2019
Jan 10
2019
Registration deadline
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