Pharma Regulatory 2018
Offering our customers the knowledge and connections for a profitable business
Speakers
  • DEBOLINA PARTAP

    DEBOLINA PARTAP Wockhardt

  • PRASHANT DESAI

    PRASHANT DESAI Johnson & Johnson

  • YASMIN SHENOY

    YASMIN SHENOY Sanofi-Aventis

  • SRIRUPA DAS

    SRIRUPA DAS Abbott

  • SHANTANU MUKHERJEE

    SHANTANU MUKHERJEE Lupin

  • KEDAR SUVARNAPATHAKI

    KEDAR SUVARNAPATHAKI Boehringer Ingelheim

  • SANJAY KUMAR

    SANJAY KUMAR GSK

  • AMITA BHAVE

    AMITA BHAVE Novartis

  • NARESH TONDARE

    NARESH TONDARE Glenmark Pharmaceuticals

  • SONIKA SHAH

    SONIKA SHAH Amgen

  • RITU JOHARI

    RITU JOHARI Abbott Diabetes Care

  • ALAP GANDHI

    ALAP GANDHI GSK

  • RANJIT BARSHIKAR

    RANJIT BARSHIKAR Editorial Member of Journal of Generic Medicine - England

  • PRATIK SHAH

    PRATIK SHAH Astellas Pharma

15th March 2018, Kohinoor Continental Hotel, Mumbai, India

"Understanding recent regulatory developments to explore innovative strategies"

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Sponsors & Exhibitors
  • Conference Info
  • Day One
  • Speakers
  • Sponsors
  • Partners
  • Sponsorship Opportunity
  • Delegates
  • Pricing
  • Venue
  • Testimonials

CONFERENCE INTRODUCTION:- 

Virtue Insight is proud to announce its first Pharma Regulatory 2018 conference.

This unique event will bring key stakeholders gather with the aim of promoting and undertaking to continue work towards a more efficient pharma regulatory system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals.

In order to succeed in this new environment, it is critical to be up to date on regulatory hurdles and be transparent in all regulatory process. The summit features government and regulatory authorities and expert insights to help you tackle and overcome these regulatory challenges, and to improve the drug and device approval processes for pharmaceutical, biopharmaceutical and medical device companies.

Virtue Insight brings you it’s first Pharma Regulatory 2018 scheduled on 15th March in Mumbai, focusing on the clarification and interpretation to the most critical regulatory guidelines faced by the Indian Pharma companies. This one day strategical summit provides insights on the US, Europe and ROW region which presents the major revenue of the top Indian pharmaceutical companies

It gives us immense pleasure in welcoming you to the Pharma Regulatory 2018
 

KEY THEMES DISCUSSED:-

  • Registration, Compliance and Approval – What next?
  • Uncommon diseases: Scientific and regulatory challenges worldwide
  • Product registration and current regulatory intels: Challenges and opportunities
  • Regional government updates on initiatives, cutting backlogs, current guidelines
  • Regulatory landscape: With data in the global regulatory and pharmaceutical surroundings what challenges and opportunities arises
  • Evaluating the regulatory anticipations, opportunities and challenges for biosimilar orphan drugs
  • Drug approval blockades - And how to operate with regulators to optimize timelines
  • Investigating the regulatory surroundings for biosimilars in India
  • The challenges of the Indian Regulation – How to adapt and when?
  • Pharmacovigilance Regulations - REMS vs RMP, PSUR Submissions, and other updates
  • Deciding better schemes for registering a variation and gaining approval in India
  • Comprehensive views on OTC product registration, License, Compliance, Safety and Risk Control
  • Cutting down the backlog of Clinical Trial and Marketing Applications – Clinical Trial Application (CTA) procedure and its timeline
  • Patient information booklet and labeling ways in Asia – How regulation analyses it?
  • Supply chain, Labelling and Distribution - Standards and cooperative strategies needed 
  • Be part of a major networking opportunity

WHO SHOULD ATTEND:-

This conference is specifically designed for pharma, biotech, CRO’s, Government and Regulators, Hospitals/Trial Sites, Technology & Solution Providers and med device professionals responsible for:

  • Regulatory Affairs
  • Regulatory Writing/Medical Writing/Publishing/Information/Submissions
  • Document and eRecords Management
  • Business Operations/Processing
  • Labelling
  • Clinical Trials Management/Data
  • Clinical Data
  • Outsourcing/Clinical Outsourcing/Vendor Management
  • Product Development
  • Quality Assurance/Quality Control

WHY SHOULD YOU ATTEND?

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:20 – Chairperson opening remarks

MARKET OVERVIEW & ANALYSIS

09:30 – Evaluating the regulatory anticipations, opportunities and challenges for biosimilar orphan drugs

  • Comparative clinical studies for biosimilar orphan drugs – Expectations of regulatory authority
  • Determining whether full-scale comparative clinical studies are always feasible
  • Surviving challenges considering determined populations and eminent costs of reference biopharmaceuticals
  • Biosimilar orphan drugs on the market - Outlining future opportunities and challenges


10:00 – Investigating the regulatory surroundings for biosimilars in India

  • Analysing Indian content and necessities for biosimilars to Europe and the US
  • Explaining whether the Indian counsel favours local companies and overcoming this hurdle
  • Considering how to work efficaciously with, and which questions to ask local associates in India
  • Researching how the market for biosimilars in India equates to the market for new entities
  • Outlining key challenges in the Indian guidance and how these can be overcome
  • Surviving regulatory CMC hurdles for developing biosimilars


10:30 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES


10:50 – DISCUSSION WITH EXPERTS: Registration, Compliance and Approval – What next?

  • Best strategies for product registration
  • Developing a product that meets authority’s requirement
  • Setting up the products in Asia – meeting regulatory and compliance requirements
  • Good Submission Practice guideline for applicants
  • Challenges in obtaining medical device product approvals from authorities
  • Regulatory Priorities and New Initiatives
  • Ideas for reducing drug approval timelines and back logs

Moderator:

Panellists:
ALAP GANDHI, Head, Medical Affairs, GSK

SRIRUPA DAS, Associate Director - Medical Affairs, Abbott

11:30 – DISCUSSION WITH EXPERTS: Uncommon diseases: Scientific and regulatory challenges worldwide

  • Dealing the strategic views, experiences and learning’s with regards to regulatory model for orphan drugs
  • Challenges faced in emerging markets
  • Communicating the experience from development process of medicines
  • Analysing the possibilities provided by the different legislations for treatment of uncommon diseases
  • Outlining the regulatory aspects that may impact approval of orphan drugs
  • Drug approval blockades - And how to operate with regulators to optimize timelines
  • Useful regulatory cooperation plans and a wish list for government intervention
  • Approval process for orphan drugs in US/ EU

Moderator:
RANJIT BARSHIKAR, QbD / CGMP Consulting, Editorial Member of Journal of Generic Medicine — England

Panellists:
RITU JOHARI, Head-Scientific Affairs, Quality & Regulatory, Abbott Diabetes Care

AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis

12:10 – Deciding better schemes for registering a variation and gaining approval in India

  • Describe key requirements for registering variations in India
  • Explaining the assortment of variations and whether this is agreed across countries in India
  • Exploring the timelines to get approval for variations
  • Surviving the key objects related with filing variations in India


12:40 Networking luncheon

Afternoon Chair Person

13:40 – Clinical research- recent positive regulatory scenario
AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis

14:10 – PANEL DISCUSSION WITH EXPERTS: Product registration and current regulatory intels: Challenges and opportunities

  • Looking into new and future changes to the regulatory area
  • Describing how changes to regulatory demands are affecting industry
  • Analysing precisely what is needed for submissions, variations and renewals
  • Surviving tight deadlines for compliance with local pharmacopeia
  • Analyzing whether to tend more towards Europe or US like needs
  • Regional government updates on initiatives, cutting backlogs, current guidelines
  • Noncompliance directions and how industry can develop

Moderator:
PRATIK SHAH, Head- Clinical, Medical & Regulatory Affairs, PV and QA, Astellas Pharma

Panellists:
NARESH TONDARE, Head– India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
PRASHANT DESAI, Director – Regulatory Affairs & Business Quality, Johnson & Johnson
SONIKA SHAH, Regulatory Affairs Head, Amgen
KEDAR SUVARNAPATHAKI, Head - Regulatory Affairs & IP, Boehringer Ingelheim


14:50 – Adapt or Perish: Big Pharma in 2017

  • Challenging times for global Big Pharma: patent cliffs, pricing pressure and generic competition
  • The GDUFA Legacy
  • Growth: beg, buy, borrow/in-license, steal
  • ‘Masala’ M&A: Indian companies, global ambitions

SHANTANU MUKHERJEE, Legal Head, Asia Pacific and Japan, Lupin

15:20 – Patient information booklet and labeling ways in Asia – How regulation analyses it?

  • News on patient leaflet and labelling in market
  • Is there any potential of patient labelling required in many markets in Asia, and regulation surrounded it
  • Preparing lay terms - challenge and solutions
  • Supply chain, Labelling and Distribution - Standards and cooperative strategies needed
  • What industry can expect after regulations changes on labelling?


15:50 – Afternoon Tea/Coffee

REGULATORY


16:20 – DISCUSSION WITH EXPERTS: Regulatory landscape: With data in the global regulatory and pharmaceutical surroundings what challenges and opportunities arises

  • Overview on current regulatory landscape
  • Developing progressive technologies as it applies to regulatory science/technology and pharmaceutical society
  • Adapting to revolutionary and developing technology (e.g. digital transformation). What are the challenges?
  • Regulatory growths to endure digitization of pharma - Solving the drivers of risk and complication of legal consequences when digitisation arises
  • Anticipation from government authorities - How is pharma operating around this?

Moderator:

Panellists:
SANJAY KUMAR, Head of Legal , Ethics & Compliance, GSK
DEBOLINA PARTAP, Vice President Legal & GC, Wockhardt
YASMIN SHENOY, Director-Regulatory Affairs, Sanofi-Aventis


17:00 Chairperson’s closing remarks and end of conference

17:10 – 18:00 Networking Drinks Session

DEBOLINA PARTAP

Vice President Legal & GC

Wockhardt

PRASHANT DESAI

Director - Regulatory Affairs & Business Quality

Johnson & Johnson

YASMIN SHENOY

Director-Regulatory Affairs

Sanofi-Aventis

SRIRUPA DAS

Associate Director - Medical Affairs

Abbott

Dr Srirupa Das has done her MD in Pharmacology from VSS Medical College, Burla and has a Post Graduate Diploma in Marketing Management from NMIMS, Mumbai. She started her career in the pharmaceutical industry in the year 2003 in Fresenius Kabi. Successively, she has had stints at Lupin Research Park and Sun Pharma Advanced Research Company before joining Abbott India Limited in 2011. Currently she is employed as Associate Medical Director-Medical Affairs responsible for Medical Affairs and governance for Abbott Primary Care.

SHANTANU MUKHERJEE

Legal Head, Asia Pacific and Japan

Lupin

Shantanu is a dual-qualified corporate lawyer, admitted in New York and India. He was recently awarded the 'Forty under Forty Rising Stars' award by Legal Era magazine.
He graduated from National Law School, Bangalore with a gold medal in Intellectual Property law; and holds an LL.M from Columbia Law School, New York.
After being admitted to the New York bar, he worked with Linklaters in New York, White & Case in Singapore and Goodwin Procter in Hong Kong.
He returned to India in 2014 as Cipla’s Global Legal Head for M&A. While at Cipla, he advised on transactions worth over USD 2.4 billion, including in the United States, China, Sri Lanka, Morocco, Algeria, Uganda, Yemen, Iran and Myanmar.

Shantanu is currently the Legal Head for APAC and Japan at Lupin Ltd., the 6th largest generic pharmaceutical company in the world by revenue, He also heads corporate legal for Lupin in India.

KEDAR SUVARNAPATHAKI

Head - Regulatory Affairs & IP

Boehringer Ingelheim

SANJAY KUMAR

Head of Legal , Ethics & Compliance

GSK

AMITA BHAVE

Head Regulatory Affairs GDD India

Novartis

NARESH TONDARE

Head - India and Nepal Regulatory Affairs

Glenmark Pharmaceuticals

Dr. Naresh Tondare is a Regulatory Expert with 11 years of experience in the areas of Regulatory Affairs/strategy, Product/Formulation Development, New Drug Delivery/Technologies  and Clinical Research.

He has completed a post graduate degree (MD) in Ayurvedic/Herbal Pharmacology and Pharmaceutical from Govt. Ayurvedic Medical College in 2004.   He has also completed a PGDIM from School of Management Studies (SOMS), New Delhi in 2009 and a Black Belt in Six Sigma (BBSS) programme from Indian Statistical Institute (ISI) in 2008.

Currently, he is working with Glenmark Pharmaceuticals Ltd, Mumbai as a Head- India and Nepal Regulatory Affairs (Senior Manager) since 2011. He is responsible and accountable for regulatory strategy and regulatory submissions of New Drug, NCE, Subsequent New Drug, OTC, Food Supplements, Herbal Products and Cosmetics for India and Nepal Region. Prior to Glenmark, he has worked with several organizations such as AccuMED, SmartAnalyst etc.

SONIKA SHAH

Regulatory Affairs Head

Amgen

RITU JOHARI

Head-Scientific Affairs, Quality & Regulatory

Abbott Diabetes Care

ALAP GANDHI

Head, Medical Affairs

GSK

RANJIT BARSHIKAR

QbD / CGMP Consulting

Editorial Member of Journal of Generic Medicine - England

PRATIK SHAH

Head- Clinical, Medical & Regulatory Affairs, PV and QA

Astellas Pharma

ORGANISED BY

Virtue Insight

Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.

Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.

SUPPORTED BY

Lex Witness

LEX WITNESS – India’s 1st Magazine on Legal & Corporate Affairs

LEX WITNESS vows to be a high quality monthly magazine with the powers of fresh and original content that would deal exclusively with subjects pertaining to legality. Country's top notch practitioners and experts are being invited to contribute in WITNESS with what we feel is relevant to all stakeholders in this profession, aiming at brainstorming between the legal luminaries and hence bettering this practice in all its aspects.

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Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.


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The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


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  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
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Kohinoor Continental Hotel

Address:
Andheri Kurla Road, Andheri ( E ), Mumbai 400059 - India
Phone:
91 22 66919000 / 91 22 28209999

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