• Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Centre of Excellence launch
• FDA approves Odactra for house dust mite allergies
• Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017
• EMA to set up technical group in the context of the publication of clinical data

• FDA allows marketing of first whole slide imaging system for digital pathology
• FDA approves new combination treatment for acute myeloid leukemia
• Optimising safety information for medicines in Europe throughout product lifecycle

• EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease
• EMA Revised guideline on first-in-human clinical trials
• FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection

• FDA awards six grants for natural history studies in rare diseases
• FDA permits marketing of device to treat diabetic foot ulcers
• Crysvita, a medicine for the treatment of X-linked hypophosphataemia, recommended for conditional approval by EMA
• Improving the availability of vaccines for animals within the EU

• FDA approves new HIV treatment for patients who have limited treatment options
• FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
• EMA surveys pharma companies on their preparedness for Brexit

• FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
• FDA approves a new treatment for PKU, a rare and serious genetic disease
• EMA: Working together for people with rare and complex diseases

• EMA: Fostering medicines for children
• EMA: New medicine for the prevention of migraine
• FDA approves new kind of treatment for hairy cell leukemia

• FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
• FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
• EMA Regulatory Science to 2025 – launch of six-month public consultation

• First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
• Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis
• FDA approves first generic Advair Diskus

• FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
• FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019
• CVMP opinions on veterinary medicinal products

• FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
• FDA approves new treatment for refractory multiple myeloma
• Global public meeting on draft ICH guideline on clinical trials

• FDA approves new treatment for patients with migraine
• Statement on concerns with medical device availability due to certain sterilization facility closures
• EMA Dialogue with Chinese authorities on medicine regulation

• FDA approves first treatment for thyroid eye disease
• FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals
• First treatment for acute hepatic porphyria

• Global regulators stress need for robust evidence on COVID-19 treatments
• Guidance on regulatory requirements in the context of the COVID-19 pandemic
• Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

• International regulators align positions on phase 3 COVID-19 vaccine trials
• Global regulatory workshop on COVID-19 real-world evidence and observational studies
• EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

• Update on rolling review of AstraZeneca’s COVID-19 vaccine
• EMA recommends first COVID-19 vaccine for authorisation in the EU
• FDA Authorizes First Direct-to-Consumer COVID-19 Test System

• FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A
• Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

• FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients
• FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

• FDA Draft Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials
• FDA Draft Guideline: Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
• Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations Can Prepare for CTIS Date: 29/07/2021 (Virtual meeting)
• ANVISA Reviews Regulations Due to COVID Pandemic.
• Possibility of remote inspections of bioequivalence centers
• Notice on Soliciting Public Comments on “Technical Guidance for the Application of Biomarkers in Clinical Research and Development of Anti-tumor Drugs (Draft for Comments)"

Conference Proceeding:

• "National Conference on Recent Trends in Pharmaceutical, Healthcare Agriculture Systems" organised by School of Pharmacy, Abhilashi University, Chail-Chowk, Mandi (H.P.)

Conference Proceeding:

• 2^nd National Convention of Indian Society of Pharmaceutical Regulatory Affairs (ISPRA)& One-week e- Faculty Development Program (e-FDP) on
• Global Regulatory Affairs in Pharmaceutical Industry: Due Diligence on Current Trends and Practices 23 - 28 January 2023
• Organised by: B. Institute of Pharmaceutical Education and Research (KBIPER),  Gandhinagar, Gujarat. India

Conference Proceeding:

• 2nd Certificate Course recognized by Indian Society of
  Pharmaceutical Regulatory Affairs (ISPRA) on Pharma
  Regulatory Affairs
  Organised by: K.B. Institute of Pharmaceutical Education and Research (KBIPER),  Gandhinagar, Gujarat. India
• COURSE COMMENCES FROM 26th JUNE 2023 to 9th JULY 2023
  (Online)