Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
New data spotlight value of Train + Test approach to close dangerous regulatory knowledge gaps.
Expert presents 3-point plan to enhance compliance education (Slide 49 and 55)
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will Be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. Please find the detailed agenda for the same with this email.
FMD:- + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
Practice Areas: New Product Planning, Business Development and Licensing, Commercial Strategy and Analytics, and Epidemiology and Forecasting.
Our boutique expertise is focused on elucidating patient benefits of bio-pharmaceutical products, medical devices, and businesses. With insightful strategies and solutions aimed at planning and growing our clients’ business, our mission is to continue being the “go-to” firm and preferred partner for our clients in their commercial planning and R&D initiatives.
Our chief operating principle is an unsurpassable commitment to quality and our philosophy has been to develop and sustain strong long-term relationships with clients based on an in-depth understanding of client needs, rigorous research, sound methodologies, and keeping ahead of industry developments.
Helping Pharmas Manage Compliance Risks for Speaker ProgramsCognizant
To avoid stiff fees, reputation damage and the imposition of corporate integrity agreements (CIAs), pharmaceuticals companies need to monitor their speaker programs carefully for compliance to a suite of regulations. We identify those rules and outline a rigorous process based on relevant key performance indicators (KPIs) that will enable pharmas to head off these potential major hits to their bottom line.
What strategies should be employed to win in Biosimilars?Santhosh R
What are the key strategies to win in biosimilars market? What should be your plan for payers, physicians, and launch? What should be the focus for pharmaceutical / biosimilar companies?
Key Takeaways -
- There is a need for a holistic approach to succeed in this market environment
- Many biologics are administered by physicians; therefore, more emphasis will have to be directed at the physicians than was the case with small-molecule generics
- Carefully constructed incentive from public and private payers / PBMs could boost biosimilar utilization significantly
- Companies need to instill confidence & awareness in patients just like they do with other stakeholders
- Launch biosimilars in emerging markets before developed markets to develop strong post-marketing data
- Manufacturing biosimilars requires scientific expertise and experience
- Success Checklist
A Regulatory Strategy for your Medical DeviceEMMAIntl
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes the approach that will be used to meet the regulatory requirements, as well as known industrial standards...
![[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)