Hall 1 Biocon Hall

Head & Neck Cancer, ICC Inauguration | Day 1, 09 Nov 2017

09:15-9:35AM How Genomics Is Shaping Precision Medicine in Oncology" and its relevance in India context - Dr. T Rajkumar

09:40-10:10AM Ablative Surgery VS Organ Preservation in Advanced laryngeal cancers - Dr. Anil D'cruz vs RT – Dr. Kannan(10mins) for each & take-home message 10mins Dr. Ashok Shenoy

10:15-10.35 AM HPV Oropharyngeal Cancers and their Management - Dr. Trimble Chairman: Dr. Ravi Mehotra

10:40 – 11:25AM

Panel Discussion: Management of Recurrence Post Primary Therapy (Dr. Govind Raj(RD), Dr. Moni K, Dr. Hasib AG (RT), Dr. Naresh Somani (M), Dr. Rekha) Moderator: Dr. Ravi Kannan Chairperson: Dr. S. Subramanium

11:30 – 12:05PM

Year - end review in H&N Cancer Med. Onc - Dr. Rejiv Ravindranath Surgery - Dr. Arvind Krishnamurthy RT - Dr. Shyam Sundar

12:10-13:30 No Session (ICC Orations)

06:30PM Inauguration: Cancer in Women - Optimizing resources "Light at the end of the tunnel" - Prof Edward L. Trimble, MD, MPH, Director, Center for Global Health

Hall 4 | Dr. BD Guptha Hall

Day 1 | 09 Nov 2017

08:00 – 09:00 AM Head & Neck - 2 PF

AROI – 3 2.30-3.30PM 3.30-

4.15PM 4.15-5.30PM

5.30

2.30-3.05 3.05-3.30 4.15-4.30 4.30-4.45

5.00-5.20 5.20-5.30

Chair persons: Dr. Virendra Bhandari, Dr. P N Pandit, Dr. Sunil Kumar

Chairpersons: Dr. Madhu Rastogi, Dr. Shankar Vangipuram

GI Current role of radiotherapy in D2 Dissection Gastric cancer. Prof Najeeb Mohideen

Toxicity in colorectal malignancy: Dr. Ravishankar B Recent Advances in Anal Canal management: Dr. Thomas Ram

Contouring challenges in Gastric malignancy. how I do it? Moderator: Dr. Ashutosh Panelists: Prof Najeeb M, Dr. Ravishankar B, Dr. Guna Seelan, Dr. Roshini,

YROC, <40 and >40 years

Hall 3 | Dr. MC Pant Hall

Day 1 | 09 Nov 2017

08:00 – 09:00 AM Head & Neck - 1 PF

AROI – 2 2.30-3.30PM 3.30-

4.15PM 4.15-5.30PM

5.30

2.30-3.05 3.05-3.30 4.15-4.30 4.30-4.45

5.00-5.20 5.20-5.30

Chairpersons: Dr. OP Singh, Dr. Anup Kumar, Dr. Sandeep Jain Chairpersons: Dr. RK Vyas, Dr. KC Sahu, Dr. Jyothirup Goswami

Lung Motion Management strategies during SBRT Lung Cancer Dr. Bhupesh Prashar

Hypo# SBRT in T1/T2 Lesions: Dr. Tejinder Kataria SBRT In Lung where we have reached. Dr. Ashu Abhishek

Panel Discussion: Has advanced technology translated into better Therapeutic outcome. Moderator: Dr. Anusheel Munshi Panelists: Dr. Bupesh P, Dr. Tejinder K. Dr. Ashu Abhishek, Dr. Shankar V, Dr. Kallur

Path breaking practice. In 21st century, SBRT and Immunotherapy Dr. Mansoor Ahmed

Contouring Challenges in peripheral vs central lesions. (+PET fusion). Dr. K C Patra

Debate: Cardiopulmanry toxicity is it hype. For Dr. Kundan S Chufal and Against Dr. Vikram Maiya

Important message to take home: Dr. Sanjib Mishra

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Hall 4 | Dr. BD Guptha Hall

Day 1 | 09 Nov 2017

08:00 – 09:00 AM Head & Neck - 2 PF

AROI – 3 2.30-3.30PM 3.30-

4.15PM 4.15-5.30PM

5.30

2.30-3.05 3.05-3.30 4.15-4.30 4.30-4.45

5.00-5.20 5.20-5.30

Chairpersons: Dr. OP Singh, Dr. Anup Kumar, Dr. Sandeep Jain Chairpersons: Dr. RK Vyas, Dr. KC Sahu, Dr. Jyothirup Goswami

Chair persons: Dr. Virendra Bhandari, Dr. P N Pandit, Dr. Sunil Kumar

Chairpersons: Dr. Madhu Rastogi, Dr. Shankar Vangipuram

GI Current role of radiotherapy in D2 Dissection Gastric cancer. Prof Najeeb Mohideen

Toxicity in colorectal malignancy: Dr. Ravishankar B Recent Advances in Anal Canal management: Dr. Thomas Ram

Contouring challenges in Gastric malignancy. how I do it? Moderator: Dr. Ashutosh Panelists: Prof Najeeb M, Dr. Ravishankar B, Dr. Guna Seelan, Dr. Roshini, Dr. Shivakumar

YROC, <40 and >40 years

Day 1 | 09 Nov 2017

Hall 5 Head & Neck – 3 PF

08:00-09:00AM Proffered Papers

ISO - 1 02:00 – 02:20 PM Case Capsules in Carcinoma Stomach

Moderator: Dr. Mahesh Goel, Mumbai Panelists:

1. Dr. Vedant Kabra 2. Dr. Yoshida, Japan 3. Dr. Shaleen Kumar 4. Dr. Atul Sharma, Delhi 5. Dr. Vinay Dhir, Mumbai 6. Dr. Kapil Kumar, Delhi

03:00 – 03:20 PM Colorectal Cancers: Liver and Lung limited disease Moderator: Dr. P K Mishra, Delhi Panelists:

1. Dr. Prasad Waghle 2. Dr. Vivek Saxena (TACE) 3. Dr. Bhavna Sirohi, Bangalore 4. Dr. Vineet Talwar, Delhi 5. Pathologist from adiyar / kidwai 6. Molecular biologist from Bangalore 7. Dr. Akash Agarwal, Lucknow

04:00 – 04:20 PM TONGUE CANCER Moderator: Dr. Preeti Jain Panelists:

1. Dr. Arun Chaturvedi, Lucknow 2. Dr. Satish Rao, Mumbai 3. Dr. Puneet Pareek, Jodhpur 4. Dr. Vijay M Patil, Mumbai 5. RT – East/ south

05:00 – 05:20 PM Management strategies in Stage III and IV larynx and hypopharynx Moderator: Mudit Agrawal, Mumbai Panelists:

1. Dr. Deepak Parikh, Mumbai 2. Dr. Surender Dabas, Delhi 3. Dr. Vinita Narona, Mumbai 4. Radiation onc from south 5. Dr. Ravi Deo, Bangalore

Day 1 | 09 Nov 2017

Hall 6 ISO

08:00-09:00AM ISO – Executive Committee meeting

ISO - 2 02:00 – 02:20 PM COMMUNITY ONCOLOGY

Moderator: Dr. S S Nayyar, Indore Panelists: Dr. Dinesh Pendharkar Dr. Rajgovind Sharma Dr. Shekhar Salkar Dr. Dixit TMH Dr. Ravi Kannan

03:00 – 03:20 PM Free Papers

04:00 – 04:20 PM LUNG CANCER: Molecular science and immunotherapy Moderator: Dr. DC Doval, Delhi Panelists:

1. Dr. Jay Mehta, Mumbai 2. Dr. Senthil Rajappa Hyderabad 3. Dr. Amit Dutt, Mumbai 4. Dr. Chacko, Vellore

05:00 – 05:20 PM Hereditary cancers Moderator: Dr. Rajeev Sareen Panelists:

1. Dr. Ashutosh Kothari 2. Dr. Amit Verma Delhi 3. Psycho oncologist from south 4. Dr. Sevanti Limaye Mumbai 5. Dr. Ismail Jatoi, USA

Day 1 | 09 Nov 2017

Hall 7 LUNG

08:00-09:00AM Proffered Papers

Eli-Lilly 01:40 – 02:20 PM Lunch Symposium on Lung Cancer -Crystal Ball

ISMPO – 1 02:30 – 05:30 PM ISMPO – Program – TBA Shortly

Day 1 | 09 Nov 2017

Hall 8 Lung Cancer

08:00-09:00AM Proffered Papers - 2

09:15 - 9:35 AM ASCO

Treatment for Advanced Squamous Cell Ca – more hope??? Dr. S Ramalingam (USA) Chairperson: Dr. Shankar Srinivasan

09:40 to 10:10 AM ASCO

Locally Advanced Adenocarcinoma - Upfront Targeted Therapy Dr. Senthil vs. concurrent CT-RT Dr. Tanmay M (10mins) for each & take-home message – Dr. B.K.M Reddy - 10mins

10:15 - 11:00 AM ASCO

Novel RT approaches for lung cancer combining RT with targeted therapies Dr. Rengan - (20 mins) VATS interventional pulmonology and pleural diseases Dr. Sai Yendamuri - 20 mins

11:05 - 11:35 AM ASCO

Panel Discussion: Advanced Lung cancer - Cutting Edge Practice Geetha(RT), Dr. Nilesh Reddy (M), (Path) Dr. Chandrika S (MB) Dr. Krishnamurthy Moderator: Dr. Vijay Agarwal

11:40 - 12:05 PM

Year - end review in Lung Cancer Med. Onc - Dr. Ullas Surgery – Dr. Rajesh Mistry RT - Dr. Rajkumar Shrimali TMC KOLKOTA

12:10 - 13:30 PM

ICC Oration

01:40 – 02:20 PM Lunch Symposium (1) by AstraZeneca

ISMPO – 2 02:30 – 05:50 PM ISMPO – 2 Program TBA Shortly

Day 1 | 09 Nov 2017

Hall 9 BMS

01:40 – 02:20 PM Checkmate in SCCHN: BMS Speaker: Dr. De Boer

IASO – 1

02:30 – 03:15 PM Panel Discussion: Management of Locally Advanced Oral Cancer

03:15 – 04:00 PM Dr. R. S. Rao Endowment Lecture - Dr. Ashok Shaha - Memorial Contribution to thyroid cancers

04:00 – 04:45 PM Symposium: WDTC - Management of Neck and Post Op Adjuvant Treatment and Follow Up

04:45 – 05:30 PM Panel Discussion: Ca. Lung - Management of N2 Disease

Day 1 | 09 Nov 2017

Hall 10 Gastric Cancer

09:30 – 10:20 AM FARO Symposium

GE junction Adenocarcinoma & early gastric cancer 1. Imaging and endoscopy Dr. Amit Maydeo 10 Mins 2. Primary Surgery Dr. Yoshida -10 mins 3. Primary Chemoradiation -10 mins (RT) FARO 4. Primary Chemotherapy- Dr. Kalaichelvi 10 Mins Wrap-up Dr. Shailesh Shrikande 5 Mins

10:25 – 10:50 AM ACOS Symposium

Oesophagus Surgical management- Dr. Sanjay Sharma (15MINS) Changing trends in Gastric Cancer in India Dr. Hemanth Raj (10Mins)

10:55 – 11:35 AM ACOS Symposium

1. Optimum treatment of Gastric Cancer - Role of surgical oncologist Dr. Han-Kwang -20 mins 2. Systemic Therapy in advanced gastric cancer -20 mins - Dr. Yeul Hong Kim Discussion - (05 mins)

11:40 - 12:05PM

Year - end review in Gastric Cancer Med. Onc – Dr. Vishwanath Surgery – Dr. Harish RT - Dr. Tanveer Shahid

12:10-13:30PM

ICC Oration

01:40 – 02:20 PM Industry Sponsored Symposium Lunch Symposium on H & N Biocon The real targeted therapy in LASCCHN

IASO – 2 02:30 – 03:15 PM Symposium: Ca. Oesophagus - NACT / CTRT followed by Surgery

04:00 – 04:45 PM Panel Discussion: Role of Extended Resection in HPB Cancers

04:45 – 05:30 PM Free Papers

Lunch Symposium 01:40 – 02:20 PM Lunch Symposium by Roche

IASO – 3 02:30 – 03:15 PM Master Videos

03:15 -04:00 PM -

04:00 – 04:45 PM Award Videos

04:45 – 05:30 PM Award Videos

Day 1 | 09 Nov 2017

Hall 11 Gastric PF

08:00 – 09:00 AM

Proffered Papers

01:40 – 02:20 PM Lunch Symposium by Roche

Day 1 | 09 Nov 2017

Hall 12 Innovation Hall

02:30 – 05:30 PM

AROI – EC / Interview

Day 1 | 09 Nov 2017

Hall 13 Galaxy Hall

08:00 – 09:00 AM

Ayush – PF

09:10 – 01:30 PM Ayush Program TBA Shortly

02:30 – 05:30 PM Ayush Program TBA Shortly

Day 1 | 09 Nov 2017

Hall 14 Cosmo Hall

Psycho Oncology

08:00 – 09:00 AM Free Papers

09:15 – 10:30 AM (A) Theme: Meeting the Psychosocial Needs of Cancer patients & their families SYMPOSIUM: 9:15-10:00 AM 1. Challenges in identifying psychological distress of cancer patients. Oncologist Perspective: Dr. Rajiv Bhatt Psycho-oncologist Perspective - Dr. Brindha Sitaram, (Bangalore) 10 minutes each 2. Meeting the psychosocial needs of cancer patients Oncologist Perspective - Dr. Antony Pais Psycho-oncologist Perspective Dr. Jayita Deodhar, Psychiatrist, (Mumbai) 10 minutes each 5 minutes Wrap up CONTROVERSY SESSION - 10.00 to 10.30am 3. Use of Psychiatric Medication: Dilemmas in Cancer care Medical Oncologist Perspective: Dr. Radheshyam Psycho-oncologist Perspective - Dr. Chitra Venkateswaran, (Kochi) 12 minutes each 6 minutes Wrap up

10:35 – 12:00 PM (B) Theme: Quality of Life Issues in Cancer KEY NOTE ADDRESS 10:35-11:05 AM 1. Neurocognitive Sequeale of cancer and cancer treatment -25 minutes Speaker: Dr. Tim Ahles 5 Mins Discussion

SYMPOSIUM: 11:05-:12-00 PM 2. Life after cancer surgery: Dealing with Psychosexual issues of patients. Surgical Oncologist Perspective: Dr. Raj Nagarkar (Nasik) Psycho Oncologist Perspective: Ms. Prapti Iyengar, (Bangalore) 08 Minutes Each 3. Quality of Life Issues in Systemic Therapies (Hair Loss, Fatigue, Insomnia etc) - Medical Oncologist: Dr. Vishwanath Apollo Psycho-oncologist: Dr. Suchitra Mehta, (Nagpur) 08 Minutes Each 4. Oncologists’ challenge in the management of Children undergoing Radiation Therapy Radiation Oncologist: Dr. Kaustav Talpatra Psycho-oncologist: Dr. Brindha Sitaram 8 Minutes Each 6 Minutes Wrap up

12:10 – 01:30 PM ICC Oration

02:30 – 03:30 PM (C) Theme: Integrating Psycho-oncology into mainstream Cancer Care SYMPOSIUM: 2.30-3.30 pm 1. Role of Psycho-oncologists in cancer care: From Prevention to Palliation & Beyond... Oncologist Perspective: Dr. Pavithran Psycho-oncologist perspective: Dr. Santosh Chaturvedi (Bangalore) 08 Minutes Each 2. Life style and Cancer: Insights and Interventions Oncologist: [Insight]: Dr. Amit Rauthan Psycho-oncologist: [Intervention]: Dr. R. Srinivas Murthy (Bangalore) 08 Minutes Each 3. Challenges in End-of-Life Care

Palliative Care Specialist: Dr. M.S R Psycho-oncologist: Dr. Manoj Kumar (Calicut) 08 Minutes Each 8 Mins Wrap-Up

03:35 – 05:05 PM CASE BASED PANEL DISCUSSION (30 minutes), 03:35 to 04:05 Moderator: Dr. V. Surendran Panelists: Dr. Thomas Verghese(S), Dr. Sanjeev Mishra, Hubli (RT), Dr. Guru Prasad (M) (D) Theme Cancer Survivorship: Plea of patients: “Was it worth it"?! SYMPOSIUM: 04: 05 to 05:05 pm 1. Children with cancer: Lost in transition from childhood to adulthood Pediatric Oncologist: Dr. Purna Kurkure Psycho-oncologist: Dr. Soumitra Datta, (Kolkata) 08 Minutes Each 2. Addressing Fertility Issues in Cancer: Complementary role of Medical and Mental health professionals Fertility Specialist: Dr. Devika Gunasheela Psycho-oncologist: Dr. Rucha Sule, (Nasik) 08 Minutes Each 3. Dealing with Fear of Cancer Recurrence Oncologist: Dr. Jagadesh Kottari Psycho-oncologist: Dr. Mahati Chittem (Hyderabad) 08 Minutes Each

05:10 – 05:45 PM (E) Dilemmas in Psychosocial Cancer Care Unique to the Indian Setting PANEL DISCUSSION: (30 minutes) 05:10 to 05:40 Moderator: Dr. Santosh Chaturvedi (Bangalore) Panelists: Dr. BR Patil(S), Dr. Vidya sagar (RT), Dr. Prasad Gunari (M) Wrap up: 5 mins

Day 1 | 09 Nov 2017

Hall 15

Chambers Hall

09:10-01:30 PM Fortis

02:30 – 05:30 PM IACA

Day 1 | 09 Nov 2017

Hall 16 Summit

02:30 – 05:30 PM FARO

SSLC

SESSION 1

14.00-15.00

Epidemiology of lung cancer in India

Chairpersons: Dr. Randeep Guleria, Delhi, Dr. G.S. Brar, Dr. Syed Altaf

14.00-14.15 Lung cancer epidemiology in India: diversity in geography Dr. P.R. Mohapatra, AIIMS,

Bhubaneshwar

14.15-14.20 Discussion (Q & A)

14.20-14.35 Profile of lung cancer in never-smokers in India Dr. K. T. Prasad, PGIMER,

Chandigarh

14.35-14.40 Discussion (Q & A)

14.40-14.55 Molecular epidemiological profile of lung cancer in India Dr. Amanjit Bal, PGIMER,

Chandigarh

14.55-15.00 Discussion (Q & A)

ISSLC Oration

15.00-15.40

Chairpersons:

Dr. D. Behera, Chandigarh (President ISSLC); Dr. Suryakant Tripathi, Lucknow (Joint

Secretary ISSLC)

Hall 17 Embassy

Day 1 | 09 Nov 2017

8th Dr Reddy’s Oration on Lung Cancer: “Managing lung

cancer in resource constrained settings: the importance of

epidemiology, molecular profiling and prognostic factors”

Navneet Singh, PGIMER,

Chandigarh

SESSION 2

15.40-16.10

Chairpersons: Dr. JK Singh, Patna, Dr. Suraj Manjunath, Dr. Murad Lala

15.40-16.05 KEYNOTE LECTURE:

Choosing the optimal sequence of targeted therapies in

metastatic NSCLC patients with driver

mutations/rearrangements

Dr. Suresh Ramalingam,

Emory University, Atlanta,

USA

16.05-16.10 Discussion (Q & A)

SESSION 3

16.10-17.10

Early Stage (Resectable) NSCLC

Chairpersons: Dr. KV Veerendra Kumar, Bengaluru, Dr. Subramanyeshwar Rao, Dr.

Ravindra Mehta

16.10-16.40 DEBATE:

16.10-16.22 Endoscopic (EBUS-TBNA & EUS-FNA) mediastinal sampling as

an alternative to mediastinoscopy for accurate mediastinal

staging

Dr. Karan Madan, AIIMS,

Delhi

16.22-16.34 Mediastinoscopy remains the gold standard for preoperative

mediastinal staging

Dr. Sabita Jiwnani, TMH,

Mumbai

16.34-16.40 Rebuttals & Discussion (Q & A)

SESSION 4

16.40 - 17.10

Chairpersons: Dr. Dinesh Katiar, Dr. Krishna Murthy, Dr.

Aravind Chennai

16.40-16.52 Management of T1/T2 central lesions: role of sleeve

resection/ carinal resections

Dr. Aravind Kumar, Delhi

16.52-16.55 Discussion (Q & A)

16.55-17.07 Importance of complete lymph node dissection during

surgical resection of early stage NSCLC

Dr. Raman Deshpande

17.07-17.10 Discussion (Q & A)

17.15-18.00 ISSLC General Body Meeting

Day 1 | 09 Nov 2017

Hall 20 Senate - I

Molecular Oncology - Precision is the key

08:00-09:00 AM Free Papers

09:15-10:00 AM

A paradigm shift - Molecular Basis for Cancer management - Are we precise enough? Chairperson Prof Sharath Chandra CHG Techniques to identify genetic mutation Prof Kondaiah, Professor, Indian Institute of Science, Bangalore(20Mins)

10:05-11:25 AM

Chairperson: Dr. Varalakshmi Hereditary Breast Cancer-Causative Genes. Dr. Ramesh Hariharan (s) - 15 Mins Cancer immunology and immuno Targets - Dr. Jayshree15 Mins Dendritic cell therapy from bench to bed side Dr. William K. Decker-15 Mins Open House - 20 Mins

11:30-12.05 AM

Panel discussion – Management on Hereditary Breast Cancer-Bench to Bedside. Dr. Ashraf Mannan(MB), Dr. Ismail Jatoi(S), Dr. Muthu Kumaraswamy(M), Dr. Vandhana Vikas(RD), Dr. Anuvinda(psy) (30 Mins) Discussion (5Mins) Moderator: Dr. Raj Shekhar Jaka

12:10-13:30 PM No Session (ICC Orations)

02:30-03:15 PM

Next Generation sequencing in Metastatic Colo-Rectal Cancer- Is it what we are looking for!!!(15 Mins)- Dr. Ajay Pandita (C) Panel discussion -Management of Metastatic Colo-Rectal Cancer Dr. Parmeshwaran, Dr. Usha Amirtham(PATH), Dr. Ajay Panditha, Dr. Nirmala (RT) Dr. Anitha (Med), Dr. Ravikanth (S) (30 Mins) Moderator: Dr. Sandhya Appachu

03:20-04:00 PM

Classification of Adeno Carcinoma Lung based on newer molecular markers (15 Mins) - Medgenom - Dr. Anuradha Chowgle TMH Panel discussion on management on Metastatic Adeno Carcinoma Lung - Dr. Urvashi Bahadur (MB), Dr. Rajesh P(RT) & Dr. Kiran Katamani(M), Dr. Kavitha (path) (20 Mins) Moderator: Dr. Sateesh

04:05-04:30PM Students Best Papers (6mins)

Hall 21 Senate II

Clinical Trials | Day 1, 09 Nov 2017

Duration Topic Panelists/Speakers

08:00 – 09:00 Free Papers

First Session ICH GCP (R2): AND ITS IMPACT ON HOW TRIALS WILL BE RUN NOW ON

9:15 AM - 10:35 AM

Overview and Objective of the Session: Biggest Change in 20 years ICH GCP (R2) how will it impact the stakeholders VS Effective Indian GCP Guidelines

Ms. Mala Srivastava - Co-founder& Managing Partner, Nextvel Consulting LLP

Panel discussion Things have changed and how will it impact global clinical trials Risk Based Monitoring Pros & Cons Auditor’s Perspective: Preparing for a Successful Audit/Inspection

Moderator: Mala Srivastava

• Dr. V G Somani-Joint Drugs Controller India, CDSCO

• Dr. Harsha Doddihal-TMH Oncologist

• Dr. Sudheer Balaraju Head Clinical Operations India, Ecron AcuNova

• Mr. Abby Abraham Director Algorics

• Ms. Chandrika Arora CEO Qmatra

• Mr. Krishnamurthy Rao COO BIOCAD

Wrap-up and Key Takeaways from the Session Dr. Harsha Doddihal/Dr. Sudheer Balaraju

Second Session: CHANGING LANDSCAPE OF CLINICAL RESEARCH REGULATIONS FROM 2009 to NOW

10:40 am to 12:05am

Overview of Changes in Indian Regulations governing Clinical Research in India from 2009 to now

• ICF & AV Consenting

• CT Inspections

• Export and Import Biological Materials

• SAE Reporting and Compensation for Clinical Trial related injury

• Guidelines for Biosimilar

Dr. Saral Thangam- CEO & Managing Director Norwich Clinical Services, Bangalore

• Role of Subject Expert Committees

• Online Submissions

• Handbook for Applicants and Reviewers Issued by ICMR & CDSCO

Compliance to Changing Regulations in Indian Clinical Regulations from 2009 onwards Which are aspects that have changed and how to ensure compliance

Panel discussion Moderator: Dr. Saral Thangam

• Ms. Rubina Bose Deputy Drugs Controller (India) CDSCO

• Dr. Raju Chacko Oncologist, CMC Vellore

• Dr. Kamal Saini, Medical Director Oncology – Covance, Belgium

• Dr. Shenaz Khaleeli, Technical Director, PharmaLeaf

• Dr. Jayasheel BG, Head - Pharmacovigilance & Regulatory Affairs at Alcon

• Dr. Gaurav Mathur- Director Regulatory, QuintilesIMS

Wrap-up and Key Takeaways from the Session Dr. Jayasheel BG

12:05 pm to 1:30pm ORATION- No parallel sessions

LUNCH 1:30pm to 2:30pm

Third Session: CHANGING REGULATION & RESEARCH ETHICS COMMITTEE OBLIGATIONS

2:30 PM - 3:40 PM Presentation: Changing Regulation & Research Ethics Committee Obligations

• Registration with CDSCO

• Accreditation of ECs

• Re-registration of Ethics

• Academic Clinical Trials

• Inspections of Ethics Committees

Dr. Sandhya Ravi Consultant Clinical Research

ICMR revised ethical guidelines to be issued highlights and changes

Dr. Roli Mathur, Scientist E, ICMR, Delhi

Panel Discussion: CR Regulations What Ethics Committee Members should know

Moderator: Dr. Sandhya Ravi

• Dr. Roli Mathur

• Dr. Denis Xavier, Professor and HOD, Pharmacology St Johns Research Institute

• Ms. Annam Visala, Deputy Drugs Controller (India), CDSCO

• Dr. Usha Rani (NIMS), Professor & Head, Clinical Pharmacology and Therapeutics, NIMS

• Dr. Raghunadha Rao

Wrap-up and Key Takeaways from the Session Dr. Denis Xavier

Fourth Session CHALLENGES IN CONDUCTING ONCOLOGY STUDIES

3:45PM - 5:00 PM Challenges of conducting Oncology Studies

• Study Design and Endpoint Evaluation

• Patient Recruitment

• Patient Compliance & Retention

• Study Conduct and Safety Reporting and Management

• Role of Site Management Organizations

Dr. Surinder Kher Independent Clinical Research Consultant

Panel Discussion: Practical Challenges and how were they overcome

Moderator Dr. Preetha Rajaramam, South Asia Program Director, USNCI

• Dr. Chetan Tamhankar, Head Clinical Development, Syngene International

• Dr. Radhika Bobba, Regional Director PSI-CRO

• Dr. Dhiraj Abhyankar, Director, Scientific Development Pharm-Olam

• Dr. Sauren Das, Executive Director Excel Life Sciences Pvt. Ltd. NOIDA

• Dr. Ramesh Jagannathan, Director and Head-Clinical Development, Dr. Reddy's Laboratories

• Dr. Suresh Attili -Oncologist

Wrap-up and Key Takeaways from the Session Dr. Dhiraj Abhyankar